NCCP-ICS joint consensus-based clinical practice guidelines on medical thoracoscopy

ABSTRACT

Medical Thoracoscopy (MT) is commonly performed by respiratory physicians for diagnostic as well as therapeutic purposes. The aim of the study was to provide evidence-based information regarding all aspects of MT, both as a diagnostic tool and therapeutic aid for pulmonologists across India. The consensus-based guidelines were formulated based on a multistep process using a set of 31 questions. A systematic search of published randomized controlled clinical trials, open labelled studies, case reports and guidelines from electronic databases, like PubMed, EmBase and Cochrane, was performed. The modified grade system was used (1, 2, 3 or usual practice point) to classify the quality of available evidence. Then, a multitude of factors were taken into account, such as volume of evidence, applicability and practicality for implementation to the target population and then strength of recommendation was finalized. MT helps to improve diagnosis and patient management, with reduced risk of post procedure complications. Trainees should perform at least 20 medical thoracoscopy procedures. The diagnostic yield of both rigid and semirigid techniques is comparable. Sterile-graded talc is the ideal agent for chemical pleurodesis. The consensus statement will help pulmonologists to adopt best evidence-based practices during MT for diagnostic and therapeutic purposes.

Medical thoracoscopy (MT) is commonly performed by respiratory physicians for diagnostic as well as therapeutic purposes and has now come to the forefront as an important diagnostic aid for the evaluation of undiagnosed pleural effusion. The earliest use of thoracoscopy dates back to 1865 and 1866 by Francis Richard Cruise and Samuel Gordon, respectively.[1,2] Semirigid thoracoscope was evaluated as a new instrument for the examination of thoracic cavity for the first time in 1998.[3] Currently, there are two methods for performing thoracoscopy namely, video-assisted thoracoscopic surgery (VATS) and MT. VATS is performed by surgeons, often under general anaesthesia. MT is generally performed by pulmonologists, and under local anaesthesia. There are distinct differences between MT and VATS.[4] The use of MT has evolved over the past few years. The Joint Consensus Position Statement of the National College of Chest Physicians and the Indian Chest Society is an attempt to provide the Indian pulmonologist with the most scientifically sound set of instructions, to follow a proper cascade of procedures as well as a practical approach to MT.

METHODOLOGY

The Consensus Statement was formulated based on a multistep process. It involved framing appropriate questions, reviewing the questions followed by an extensive critical appraisal of the relevant literature in English and reaching a recommendation by the expert groups. The literature search process began in January 2022 and continued up to September 2022. The practical aspects of MT were discussed by the expert group members and a set of 31 questions were framed to address common dilemmas faced by pulmonologists for using MT. A systematic search of published randomized controlled clinical trials (RCTs), open labelled studies, case reports and guidelines from electronic databases (PubMed, EmBase, Cochrane) were reviewed to find the answers to the questions posed for framing the consensus statements. A meeting of the Expert group and executive subgroups was convened. The recommendations were presented to the Joint working group by each of the executive subgroups. The evidence-based consensus statements were finalized and were used to formulate the final consensus recommendations. The modified GRADE system was used to classify the quality of available evidence as level 1, 2, 3, or usual practice point, as given in Table 1. The strength of recommendation was graded as A or B based on the quality of evidence available, applicability and generalizability to the Indian population, and ease of implementation in the real-world setting. [Table 1].

Table 1.

Quality of evidence and recommendations

Quality of Evidence	Level
Evidence from >1 well-conducted RCT or meta-analysis of RCTs	1
Evidence from at least 1 moderate quality RCT, or well-designed trial without randomization, or cohort/case-control studies	2
Evidence from descriptive studies, reports of expert committees, or opinions of respected authorities based on clinical experience	3
Not backed by sufficient evidence; however consensus, reached by Working Group based on clinical experience and expertise	UPP
Strength of Recommendations	Grade
Strong recommendation to do (or not to) where the benefits clearly outweigh the risks (or vice versa) for most, if not all patients	A
Weak recommendation, where the benefits and risks are more closely balanced or are more uncertain	B

MT is now the second most important endoscopic technique in respiratory medicine, after bronchoscopy.[5] It is indicated for the management of a variety of pleural diseases.[6] MT facilitates a direct inspection of the pleura and biopsies can be taken under direct vision, leading to a high diagnostic yield. The technique and clinical applications of MT have evolved over time and expanded over the past few decades.[7] It can be done by well-trained physicians, either pulmonologists or thoracic surgeons.[1]. With improving proficiency and an increasing number of interventional pulmonologists, MT is poised to come to the forefront as a useful diagnostic and therapeutic tool in pleural diseases.[8] MT is generally a safe procedure.[5] If mastered well, it helps to improve diagnosis and patient management, with reduced risk of postprocedure complications.[9]

The diagnostic yield of MT can be as high as 91–95% for malignant disease.[10,11] Pleural tuberculosis is associated with serious long-term morbidity, and it poses diagnostic challenges due to its paucibacillary nature and requires culture and molecular techniques to arrive at the diagnosis. Pleural biopsy is generally diagnostic and it can be done by image-guided closed pleural biopsy, but thoracoscopy provides the best results.[12] MT is also considered in patients with undiagnosed pleural effusion in whom no diagnosis has been reached after either clinical, radiologic, laboratory, or cytologic investigations.[10,11,12]

Q1: What are the indications contraindications and complications of thoracoscopy?

Considerable heterogeneity exists in the approach to the diagnosis of pleural diseases. The differences in resources, trained personnel and paucity of high-quality evidence preclude a clear choice of the diagnostic technique to be adopted.[13]

Appropriate treatment of pleural effusions can be initiated once the aetiology has been defined. However, in about 20% of patients with pleural effusion, the aetiology remains unclear.[14] MT is particularly effective in pleural effusion of unknown aetiology. In the study by Wang et al.,[15] pleural biopsy through MT resulted in a definite diagnosis of non-Hodgkin’s lymphoma in 9 out of 10 (90%) patients with malignant pleural effusion (MPE).

Another indication of MT is the staging of lung cancer with pleural effusion and diagnosis of malignant mesothelioma. The study by Shu-Juan Jiang et al.[16] demonstrated the utility of MT in differentiating malignant nodules from tuberculous nodules. Gao BA et al.[17] evaluated 215 patients with undiagnosed exudative pleural effusion using flexi-rigid thoracoscopy. They concluded that flexi-rigid thoracoscopy had a high diagnosis rate and helped in arriving at the diagnosis in patients with exudative pleural effusion of unknown aetiology with a reasonable degree of effectiveness and safety.

The diagnostic indications for thoracoscopy include the following: 1. pleural effusion of unknown aetiology (malignancy, tuberculosis, etc.), 2. staging of lung cancer with pleural effusion, and 3. malignant mesothelioma.[4]

The therapeutic indications for thoracoscopy are the following: 1 Talc poudrage in malignant and chronic recurrent nonmalignant pleural effusions, 2. Talc poudrage in recurrent pneumothorax-unfit for surgery and 3. Parapneumonic effusions and empyema (for breaking adhesions in early stages).[4]

MT is useful for talc poudrage in malignant and chronic recurrent nonmalignant pleural effusions. In patients with malignant pleural effusion, thoracoscopic talc poudrage is comparable to talc slurry delivered via chest tube in terms of pleurodesis failure rates at 90 days (22% vs 24%).[18]

Thoracoscopic talc poudrage is also effective to stop recurrence of pleural effusions.[19] Talc poudrage is useful in recurrent pneumothorax cases unfit for surgery. Pleurodesis with talc poudrage is efficacious and well tolerated, especially with the use of large-particle talc.[7]

The optimal management of loculated parapneumonic effusions and empyema consists of the breakdown of adhesions to facilitate the drainage of infected pleural fluid. Intrapleural fibrinolytics such as urokinase enhance intercostal tube drainage and reduce the need for subsequent surgical mechanical debridement.[22,23]

The most effective fibrinolytic therapy study to date is intrapleural t-PA-DNase therapy which improved fluid drainage in patients with pleural infection and reduced the frequency of surgical referral and the duration of the hospital stay.[24] The contraindications to perform medical thoracoscopy are enumerated in Table 2.

Table 2.

The contraindications to performing medical thoracoscopy[20,21]

Absolute contraindications	Relative contraindications
• Lack of Pleural space	• Inability to tolerate lateral decubitus positioning.
• Extensive intrapleural adhesions	• Refractory cough
• Fusion of parietal and visceral pleura	• Reduced general health status with short suspected survival
• Post pleurodesis	• Unstable cardiovascular or hemodynamic status
• Hypercapnia or severe respiratory distress	• Significant comorbid disease
• Uncorrectable coagulopathy	• Coronary artery disease (recent ACS within 4 weeks)
• Lack of informed consent	• Uncontrolled airway disease
	• Uncontrolled seizures
	• Pulmonary arterial hypertension
	• High likelihood of trapped lung
	• Presence of central airway tumour
	• Contra-lateral significant lung disease
	• Morbid obesity
	• Drug hypersensitivity
	• Active sepsis (unless due to empyema or parapneumonic complicated effusion)
	• Severe pulmonary fibrosis
	• Visceral pleura is fragile and high chance of persistent air leak

Consensus statement 1

• For undiagnosed pleural effusion, MT has higher yield and better safety profile than unguided closed pleural biopsy (Level 1, Grade A)

• For undiagnosed pleural effusion, the yield of thoracoscopic biopsies is similar to image-guided closed pleural biopsies, in patients having pleural abnormality on imaging (Level 1, Grade A)

• We recommend MT/image-guided pleural biopsy over unguided closed biopsy for diagnosis of pleural effusion undiagnosed after initial thoracocentesis (Level 1, Grade A)

• We recommend MT over image-guided pleural biopsy for staging potentially resectable lung/extrathoracic malignancy (Level 2, Grade B)

• In cytology positive malignant pleural effusion, MT may be done to obtain tissue for molecular diagnostic studies (where cell block is inadequate) (Level 3, Grade B)

• Medical thoracoscopy is overall a safe procedure with negligible mortality (Level 1, Grade A).

Q2: What is the competency (knowledge and skills) required to perform thoracoscopy?

The postgraduate teaching programmes in Indian medical colleges vary in terms of the faculty as well as the facilities and the availability of infrastructure. Hence, the training and expertise is not uniform. In spite of the exponential increase in the number of MT procedures performed, no guidelines have been formulated to ensure that the basic skills and competency are adequate for pulmonologists, critical care physicians, or thoracic surgeons to perform MT.

The knowledge required encompasses the precise topographical anatomy of the thorax and the pathophysiology of respiratory diseases. The operator must become familiar with the technique of MT including all instruments used, the different options to access the pleural space and the technique of coagulation.[25] The skill set to be developed is listed in Table 3. Technical skills can best be learned under the direct supervision of an experienced thoracoscopist/mentor. There is a learning curve before full competence in MT is achieved.[25]

Table 3.

The skill set and personnel required for MT

Skill set to be developed for performing medical thoracoscopy	• Thoracic ultrasonography
	• Familiarity with instruments used
	• Administration of local anaesthesia and procedural sedation
	• Diagnostic and therapeutic thoracentesis
	• Different options to access the pleural space
	• Familiarity with chest tube insertion and drainage
	• Pleurodesis techniques
	• Familiarity with biopsy forceps and coagulation technique
	• Complete anatomy of thoracic cage/lungs/heart/mediastinum/pleura
Personnel required	• Physician performing the procedure
	• An endoscopy assistant: (a nurse/respiratory therapist/young doctor/trainee)
	• For assistance during instrumentation
	• To handle the specimens during the procedure
	• A nurse for:
	• Monitoring patient’s vital parameters: during and post procedure
	• Titration of sedation
	• All supporting personnel should be familiar and competent to respond to an emergency situation

Currently, there is a lack of evidence regarding the number of supervised and/or independent thoracoscopic procedures that are required to achieve competency and to maintain the skill. As such clear training guidelines and competency standards remain to be developed by major associations/organizations. Some countries have fellowship programmes for training in interventional pulmonology.[13]

Consensus statement 2

• Trainees should perform at least 20 medical thoracoscopy procedures in a supervised setting to establish basic competency (UPP)

• A minimum of 10 medical thoracoscopy procedures per year must be performed to maintain competency (UPP).

Q 3: Where should thoracoscopy be performed: in operating theatre (OT) or in the bronchoscopy suite?

A clean endoscopy suite would be appropriate for performing MT. Additionally, a premedication area, a washroom and an area for cleaning and sterilising instruments must be available.[25] If an endoscopy suite is not available, MT could be performed in an operation theatre.

Consensus statement 3

• We recommend that medical thoracoscopy be performed under complete aseptic precautions in a clean endoscopy suite or in the OT (UPP)

Q 4: Which scope is preferred for performing a thoracoscopy: rigid, semirigid, or mini-rigid?

The most commonly used thoracoscope for MT is the conventional rigid thoracoscope.[26,27] The semirigid thoracoscope was developed to combine the best features of the rigid thoracoscope and the flexible bronchoscope. Randomized clinical trials have compared the diagnostic yield of conventional and semirigid thoracoscopes and have demonstrated that the diagnostic yield of both the instruments is similar if adequate pleural tissue is obtained.[26,27] The rigid thoracoscope allows the operator to obtain an adequate or larger-sized pleural biopsy specimen more consistently as compared to the semirigid thoracoscope. The rigid thoracoscopies are superior to the semirigid thoracoscope when performing adhesiolysis.[28,29] However, the advantages of the rigid thoracoscope are countered by the increased incidence of procedure-related pain due to the pressure and angling of the rigid instrument over the periosteum[30] and a greater need for sedation/analgesia as compared to a semirigid thoracoscope.[31,32] The semirigid pleuroscope provides a greater degree of flexibility[3,33] and allows the operator to negotiate around a nondeflated lung or dense adhesions. The biggest advantage of the semirigid thoracoscope is the ease of handling by the operator, the grip being almost similar to a bronchoscope.[29] Semirigid thoracoscopy can be considered a safe method for the evaluation of pleural diseases and for performing therapeutic talc pleurodesis.[34] However, the role of closed pleural biopsy should not be undermined in resource-poor setting.[35]

In a survey of MT practices in India with 108 respondents, 42% of the respondents were using rigid instruments and 29% were using semi-rigid thoracoscopes.[36] Around 26% of respondents were using both rigid and flexi-rigid thoracoscopes. Only 3% of the respondents used a flexible bronchoscope for thoracoscopic examination and 8.3% of the respondents were using the mini-thoracoscopes.[36]

Consensus statement 4

• The diagnostic yield of both rigid and semirigid thoracoscope are comparable (Level 1, Grade A)

• Rigid thoracoscopes allow for retrieval of significantly larger specimens compared to the semirigid scopes (Level 1, Grade A)

• Rigid thoracoscopy is preferred in difficult to biopsy pleura or in case of adhesiolysis (Level 3, Grade B)

Q 5: Should endoscopic electro-cautery be used in MT?

The biopsy size obtained using standard flexible forceps (SFF) during pleuroscopy is often inadequate for pathological examination, particularly when fibrotic pleura is encountered. An insulated-tip diathermic knife (IT knife) facilitates safe resection of a larger lesion during gastrointestinal endoscopy.[37] There is a lack of robust evidence regarding a comparison between IT knife with standard flexible or rigid forceps biopsy during MT. In the study by Sasada et al. 2009,[37] the electro-cautery using IT knife was directly compared with SFF during thoracoscopy in 20 patients with unexplained pleural effusion. The diagnostic yields from specimens obtained with the IT knife and SFF were 85 and 60%, respectively. The size of the biopsy specimen was larger with IT. Also, electrocautery biopsy using the IT knife allowed the biopsy of smooth abnormal pleura, which was difficult to biopsy with SFF. There were no severe complications during the procedure.[37] Currently, the diathermic knives are also used in instances such as the extremely rare extra nodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) arising from the pleura, the rare desmoplastic malignant mesothelioma and large early gastric cancers.[38,39]

Consensus statement 5

• Pleural biopsy using electrocautery with diathermic knife (IT knife) inserted via a thoracoscope may be used in selected cases over and above SFF in cases of pleura with no obvious nodularity but with a high clinical suspicion of malignancy (Level 3, Grade B).

Q 6: Is pleural cryobiopsy superior to rigid/flexible forceps biopsy?

Conventional forceps biopsy is practiced during MT. The diagnostic yield of a cryoprobe is comparable to flexible or rigid forceps.[40] Cryobiopsy is safe and feasible when used with semirigid thoracoscope.

The cryoprobe biopsy is a highly effective and safe method to obtain pleural biopsy. It has the advantage of good quality specimens especially from thick firmly adherent pleura.[41] Cryobiopsy samples are of good quality with better-preserved cellular architecture and tissue integrity for pathologic and immuno-histochemistry (IHC) evaluation as compared to flexible/rigid forceps.[41] Also, Cryobiopsy technique decreases the procedural time.[41,42,43]

Cryoprobes used for transbronchial lung biopsy obtain larger specimens, increase the depth of sampled tissue and have less crush artefact.[44,45] Similar results were reported in the systematic review and meta-analysis of 15 studies.[46] However, this meta-analysis did not show the superiority of cryobiopsy for diagnostic yield. Further studies are still required to corroborate these findings. Other smaller studies have also demonstrated comparable yields of cryobiopsy versus conventional forceps biopsy (99% vs 96%)[40] Cryotechnique has the potential to play an important role in MT in the near future when rigid thoracoscopy may not be available.[47]

Consensus statement 6

• Pleural cryobiopsy is a safe procedure (Level 1, Grade B)

• There is no difference in the diagnostic yield between cryobiopsy versus forceps biopsy. We do not recommend routine use of cryopleural biopsy (Level 1, Grade B)

• Cryobiopsy can be preferred in difficult to sample pleura (UPP)

Q7. Prerequisites for medical thoracoscopy

A detailed history of comorbid disorders including occupational exposure, medication/radiation, connective tissue disorders, etc., should be taken. A thorough physical examination is as important as the history of the patient. The examination is also required for assessing the site of insertion (intercostal space), presence of obesity and ability of patients to lie in the lateral position. Radiological investigations like chest radiograph and ultrasonography (USG) of chest and abdomen are equally essential. The USG of the chest is required to assess the site of insertion of trocar, whereas USG abdomen is useful in ruling out the abdominal cause of pleural effusion, e.g. liver abscess. The computed tomography (CT) of thorax is useful for assessing the cause of pleural effusion, site of insertion and correlation of lesion with other intra-thoracic organs. The presence of a moderate to large pleural effusion may often hide pathology in the underlying lung. Both USG and CT chest are useful in assessing the adhesions, which can decide if a rigid or semirigid thoracoscope will be required. We can recommend a CT scan before diagnostic thoracoscopy in situations when there is a pleural effusion with no mediastinal shift, mass with effusion, to look for mediastinal nodes in patients with pleural effusion where there is high suspicion of malignancy, etc.

It would be prudent to evaluate the respiratory status in terms of saturation and vital capacity, i.e. arterial blood gas analysis and pulmonary function tests. This is because thoracoscopy may cause hypoventilation due to sedation, lateral decubitus position and creation of artificial pneumothorax. Also, if the patient has postmyocardial pleural effusion or underlying cardiac disease leading to arrhythmia there may be procedure-related complications. If steroids were being given, chances of postprocedure infections increase. The use of anticoagulants due to cardiac disease can lead to postprocedure bleeding.[13,25,48,49]

Consensus statement 7

• The prerequisites are listed in Box 1. (UPP)

Box 1: Prerequisite for the procedure[13,25,48,49]

• A preprocedure 24-h chest radiograph, ECG.

• A routine blood test, blood coagulation series, blood type, hepatitis B and C and human immunodeficiency virus evaluation.

• Cardiopulmonary function assessment within the last 7 days.

• The patient should be able to lie down in the lateral decubitus position,

• Allergy to sedation and any other medication should be documented,

• The anticoagulants should be withheld in the following manner:

  • Warfarin: 5 days
  • Clopidogrel: 5–7 days
  • Dabigatran: 2–4 days
  • Rivaroxaban: 2–3 days
  • Apixaban: 1–2 days
  • Enoxaparin: 24 h
  • Fondaparinux: 24 h
  • Heparin IV: 4–6 h
  • Aspirin: 1 day

• The patient should be ideally hospitalised for a daycare procedure,

• Pleural ultrasound should be preferably performed and available during the procedure,

• Preprocedure fasting of 6 hours

• The procedure should be undertaken by a properly trained interventional pulmonologist,

• A minimum of two other suitably trained health-care personnel are required for assistance, monitoring and administration of the intravenous (IV) sedation.

• The procedure room must have the following:

  • Pulse-oximetry, noninvasive blood pressure recording, electrocardiogram monitoring
  • Resuscitation equipment, defibrillator
  • Oxygen source
  • Height-adjustable procedure table
  • Suction equipment
  • Trolley to hold instruments
  • Facilities to display patient’s radiographs.

Q 8. Informed consent and fitness for medical thoracoscopy

It is essential to obtain written informed consent before thoracoscopy. The patient should be given a detailed information sheet describing the procedure before obtaining consent (Supplementary Annexure 1). Coagulation studies (prothrombin time, international normalized ratio and activated partial thromboplastin time) should be performed routinely in patients planned for thoracoscopy. Similarly, all the routine investigations including complete blood count with platelet count, blood sugar, renal and liver function tests should be obtained in all the patients. Viral markers (HIV/hepatitis B/hepatitis C) are required before thoracoscopy[36]

While taking consent it is important that patient has the understood the indication and the type of procedure. A detailed written informed signed consent explaining the following should be taken.

1. aPurpose and nature of the procedure and anaesthesia

2. b.The potential benefits and risks of the procedure

3. c.The likely result is if the patient does not have the recommended procedure/intervention.

4. d.The available alternative treatments and their benefits and risks.

The details of the consent form and patient information sheet are given in supplementary annexure 1.

Consensus statement 8

• Consensus statement: An informed consent must be obtained from the patient, prior to the procedure explaining the reasons and the possible complications of medical thoracoscopy. A detailed patient information sheet should be supplied and explained to the patient detailing the procedure and postprocedure instructions for seeking medical care. (Level 1, Grade A)

Q 9: What is the appropriate position and site of the insertion of the thoracoscope?

The use of portable devices allows patient’s bedside evaluation and provides rapid, real-time diagnostic information.[21,50] The patient is placed in a lateral decubitus position with a diseased side up. The arm of the affected side may be kept in front and a sandbag or a rounded bolster may be kept below the patient to widen the rib spaces to provide sufficient space for entry of the thoracoscope.[51] The site of trocar insertion should preferably be guided with the help of on-site ultrasonography to detect the best site. In case of nonavailability of the ultrasound, insertion may be done in mid-axillary line in the third or fourth intercostal spaces in recurrent pneumothorax and in the sixth to seventh space in pleural effusions of undiagnosed aetiologies. [Table 4][51] Single-port entry is preferred, and double-port entry is recommended in patients requiring adhesiolysis and complicated pleural effusions.[21,51] The double-port technique is best left to the surgeon or the very experienced medical thoracoscopist.

Table 4.

Site of insertion of a thoracoscope

Indication of MT	Site of insertion
Pleural effusion	5–7th intercostal space
Metastatic tumours, diffuse malignant mesothelioma	6–7th intercostal space
Pneumothorax	3–4th intercostal space
Adhesiolysis, complex empyemas, lung biopsy	Double port technique

Consensus statement 9

• The position of the patient should be lateral decubitus with the diseased side up (Level 3, Grade A)

• The site of insertion of trocar should be decided preferably with ultrasound guidance. (Level 3, Grade A)

• In case of nonavailability of the ultrasound, insertion may be done in the safe triangle in fourth to sixth intercostal space with clinical and radiological correlation after confirming with needle aspiration of fluid/air freely. (UPP)

• Single-port entry should be preferred. (Level 3; Grade A)

• In patients requiring adhesiolysis and with complicated pleural effusions, MT should be done preferably by a surgeon or an experienced operator using double-port entry. [UPP]

Q 10: What is the appropriate anaesthesia / sedation for MT?

MT is commonly performed under local anaesthesia with moderate sedation. The British Thoracic Society Guidelines on pleural procedures state that lidocaine 1% (10 mg/ml) is the most commonly used local anaesthetic at a dose up to 3 mg/kg (maximum: 250 mg = 25 ml).[48] However, there is no consensus about the maximum dose which can be used. A dose of up to 4.5 mg/kg has been used without any significant increase in adverse effects. The combination of lidocaine (1%) with adrenaline (1 in 200,000) allows a larger dose of up to 7 mg/kg (maximum: 500 mg in 50 ml).

If MT is performed under conscious sedation (patients remain awake or arousable during the procedure, and are breathing spontaneously, without intubation), an anaesthetist is not required.[25] A combination of benzodiazepines (midazolam or lorazepam) and narcotics (morphine or fentanyl) helps to achieve further analgesia and conscious sedation.[4] Propofol use requires monitoring of anaesthesia by an anaesthetist and, hence, propofol must not be considered as the drug of choice for MT.[52,53] If the anaesthesiologist is available, then propofol may be used. Propofol use is associated with higher incidences of hypoxemia and hypotension and sudden cardiac arrest. General anaesthesia may be preferred in some patients who have hypersensitivity to local anaesthetics, or have excessive anxiety or are noncooperative, in children and in patients who require advanced techniques (such as sympathectomy).[25]

Consensus statement 10

• Local anaesthesia and conscious sedation with analgesia should be used for MT (Level 2, Grade A).

• A combination of narcotic preferably fentanyl and a benzodiazepine, preferably midazolam, should be used (Level 2, Grade A).

• Propofol may be used with monitored anaesthesia care in special situations (Level 2, Grade A).

Q 11: Should the thoracoscopist use personal protective equipment (PPE) during the procedure?

As MT is an invasive procedure in a bronchoscopy suite, routine infection control practices for any invasive procedure should be employed for maintaining sterility and avoiding transmission of any infection. Evidence on the use of PPE during thoracoscopy is limited. Testing for COVID-19 should be done as per prevailing local/regional/institutional guidance. Infections like Coronavirus disease 19 (COVID-19) and other respiratory infections like drug-resistant tuberculosis and multidrug-resistant tuberculosis mandate the use of protective gear to prevent the thoracoscopy team from catching any infection. Symptomatic patients may be tested for COVID-19 prior to MT by reverse transcriptase polymerase chain reaction. If it is negative, PPE can be avoided and standard surgical precautions can be adopted. If the test is positive, thoracoscopy should be deferred till it becomes negative. If MT must be necessarily performed in a patient with a transmissible viral, mycobacterial or bacterial pulmonary infection, all members should don a fitted N95 respirator mask with droplet attire (gown, gloves and eye protection). The use of PPE has been shown to provide a high level of protection even in the face of heavy exposure in very high-incidence areas.[54,55,56,57,58]

Consensus statement 11

• Universal precautions for infection control and personal protection should be taken by all thoracoscopy suite staff maintaining standard surgical aseptic precautions (Level 2, Grade A)

• When COVID-19 is suspected, all members of the thoracoscopy suite should don a fitted N95 respirator mask. PPE including water-resistant gowns, gloves and eye protection should be used as per the institutional infection control policy. (UPP)

Q 12. What resuscitative equipment and drugs should be present in the thoracoscopy suite?

Standard medical thoracoscopic procedures are safe and effective for the diagnosis and treatment of pleural and pulmonary diseases. However, the risk-benefit ratio must be considered for each patient.[21,59] However, an adequately equipped resuscitation cart with all necessary emergency drugs must be kept available in the throracoscopy suite for deployment in case of any emergency.

Consensus statement 12

• To deal with any unexpected contingencies during thoracoscopy a well-equipped resuscitation cart should be available in the thoracoscopy suite. (UPP)

Q 13. Is there any role of antibiotic prophylaxis in patients undergoing MT?

Thoracoscopy is routinely conducted under a sterile environment and under aseptic precautions. The risk of secondary infection is very low as long as sterility is maintained. Immunocompromised patients such as patients with asplenia, solid organ transplant, on oral steroids, immunosuppressive agents or HIV-AIDS have a theoretically high risk of infection. However, the study by Dhooria et al.[60] indicated that there was no association between age, comorbid illness (diabetes mellitus or chronic kidney disease), type of thoracoscope used, duration of procedure, histological diagnosis (benign or malignant) and the occurrence of infections in the postprocedural period. The use of a single dose of an antibiotic prior to MT was not associated with a reduction in the occurrence of postprocedural infection.[60]

Consensus statement 13

• Use of antibiotics prior to thoracoscopy is not recommended in routine or even immunocompromised patients. (UPP)

Q 14. i Sterile techniques – positioning/cleaning and draping/technique of local anesthesia (LA)/dissection/trocar placement/fluid removal/induction of pneumothorax/visual examination technique and sequence

There are no studies available to address specific questions such as sterile technique, cleaning and draping, technique of local anaesthesia, dissection and trocar placement, fluid removal, induction of pneumothorax and visual examination technique and sequence. Hence, the usual clinical practice based on experience from various medical thoracoscopists offers the best practice points, specifically considering the invasiveness of the procedure, the setting, possible complications and in the general interest of patient safety for a successful procedure. The ensuing section is based on an amalgamation of experience from experts performing MT.

Cleaning and Draping

Preoperative preparation: The physician and assisting personnel should follow standard surgical cleaning techniques and wear sterile surgical gowns and gloves. The patient’s skin is prepared by shaving and disinfecting a larger area beyond the surgical site. This allows potential for different points of entry and reduces accidental contamination. The area cleaned should extend from the clavicle above to the base of the thorax below, from the sternum anteriorly to the medial border of the scapula up to the spinous processes of the vertebra posteriorly and covering the entire axilla.

The area is cleaned with iodine, alcohol or chlorhexidine- based solutions. The action of antiseptic agents is time dependent so adequate time for drying should be allowed as per manufacturer’s recommendation. Three to five minutes are routinely given for povidone-iodine solution. The patient is covered with sterile sheets extending beyond the operative area.

Site of incision

Mid-axillary line from third to seventh intercostal space (ICS) depending on indication of thoracoscopy and underlying lesion. An axillary triangle is preferred. This prevents large muscles from obstructing the instrument passage. The margins are anteriorly – pectoralis major, posteriorly – latissimus dorsi, base – diaphragmatic insertion and apex – second inttercostal space. An incision along mid-axillary line is preferred. Pleural effusion/pleural lesions’ evaluation needs fifth to seventh intercostal space. These spaces provide a better view of the diaphragm and costo-vertebral gutter where malignant lesions are usually found. In patients with pneumothorax, third or fourth ICS is preferred as it allows better visualization of the lung. The mid-axillary line in the fourth or fifth ICS is the most used site of entry.

Technique of local anaesthesia

A previously marked site of entry is palpated, and a small wheal is raised by intradermal injection of lidocaine. In a sequential manner, the skin, subcutaneous tissue, intercostal muscle and parietal pleura along with peri-ostium of the ribs directly above and below should be infiltrated. The needle should be kept perpendicular to the chest wall, and inadvertent insertion in a vessel should be checked by repeated suction of the syringe plunger. When parietal pleura is crossed, there is a feeling of give way, and we may aspirate air or fluid. Cautiously, we go further in and aspirate the fluid.

Induction of pneumothorax

In case of preexisting large pneumothorax or large pleural effusion, induction of pneumothorax is not required and trocar can be inserted directly. Artificial pneumothorax is required to be created before inserting trocar if there is not adequate intrapleural air/fluid. However, these procedures should be done by well-trained pulmonologists and at centres well versed in such procedures. Major pleural adhesions should be ruled out by prior imaging. If the patient has preexisting intercostal drainage (ICD), mere disconnection from the underwater seal followed by deep breathing might be adequate to induce pneumothorax. In case of small/localized effusion or pneumothorax, the site should be localized preoperatively by X-ray and contrast enhanced computerized tomography (CECT). The needle is inserted in the marked site, and once we are in the pleural space, the needle is disconnected from the syringe. Although air enters spontaneously through the needle, the patient can be asked to take deep breaths. In patients with no effusion or pneumothorax special pneumothorax induction, needles (blunt tipped) can be used, e.g. Deneke, Veress, Saugmann or Boutin needles with or without a manometer or a pneumothorax induction device. Artificial pneumothorax can also be introduced by blunt dissection using a finger.

In patients with pleural adhesions, preprocedure ultrasound is performed to localize the site and the pleural space should be entered distant from adhesions. A blunt dissection is performed with finger to break adhesions before advancing the trocar.

Dissection technique

The mid-axillary line the fourth or fifth ICS is the most used site of entry. A superficial incision in skin is given. The size depends on the instrument being used. For a semirigid thoracoscope, a 1-cm incision is sufficient as the trocar used has an outer diameter of 10 mm. For the rigid thoracoscope, the incision size depends on the size of trocar and the scope being used. The second incision if needed for the rigid thoracoscopy is taken one intercostal space above or below the site of the first incision. Usually smaller incision (5–7 mm) is used for instrumentation.

Dissection and trocar placement

The incision is given in the middle and parallel to the ICS. A blunt artery “Kelly” forceps is used to dissect muscle layers and subcutaneous tissue till parietal pleura is breached (loss of resistance). The trocar should be inserted perpendicular to the chest wall with corkscrew movements while using a finger or thumb placed on the chest wall to guard against sudden inward movements and potential lung injury. Once the loss of resistance is felt, the inner trocar is removed and the outer cannula is pushed 1–3 cm inside the pleural space. The outer cannula should be secured in position by an assistant.

Visual examination

After trocar insertion, the entire fluid must be aspirated slowly to allow for slow expansion of the collapsed lung. Complete removal of fluid allows for good visualization of pleura. Removal of fluid should be slow to avoid undue negative pleural pressure and risk of developing unilateral re-expansion pulmonary oedema (REPE). The thoracoscope is initially directed caudally and posteriorly towards the diaphragm and costo-phrenic recess to drain the entire pleural fluid. Adhesions can interfere with proper visualization and can be broken/removed with the scope, forceps, cautery or laser (whichever is available). The entire pleural space should be inspected in a systematic fashion including the pleural surfaces over diaphragm, chest wall, mediastinum, apex and whole of the lung surface covered by visceral pleura. Although entire parietal pleura must be examined, there is no standard sequence for visualization.

Consensus statement 14 i

• Thoracoscopy should be done in lateral decubitus position with the affected side facing up. (UPP)

• Strict sterile conditions must be maintained during thoracoscopic procedures. (UPP)

• Choice of antiseptic agents – alcohol, chlorhexidine or povidone-iodine based on the clinicians’ choice. Appropriate and agent specific time should be allowed after the application of the antiseptic before starting the procedure. (UPP)

• Induction of pneumothorax is not needed in case of underlying large pneumothorax or pleural effusion. In absence of significant adhesions, pneumothorax can be induced by pneumothorax induction needles or blunt dissection with finger. (UPP)

• We recommend appropriately sized skin incision (depending on trocar size) in fourth or fifth ICS in midaxillary line followed by blunt dissection. Depending on the indication, the site of entry may be changed based on preprocedure imaging (Ultrasound/CT). (UPP)

• We recommend guarded trocar insertion followed by complete fluid removal for proper visualization of entire pleural surfaces. (UPP)

• We do not recommend any specific sequence of visual examination. A thorough examination from apex to diaphragm including diaphragmatic pleura and costophrenic angle, mediastinal pleura, costal pleura and apex should be done. Corresponding lung surfaces should be examined simultaneously. (UPP)

Q 14: ii: How much pleural fluid should be removed during thoracoscopy?

The major complication of rapid volume change in pleural space is REPE. It can involve ipsilateral, contralateral and even bilateral lungs. The risk of REPE after thoracoscopy is rare, with only few reported cases and no mortality has been reported. Only anecdotal evidence is currently available.[61] There are some observational or retrospective studies which have reported the development of REPE in patients undergoing thoracoscopy.[9,27,62,63] In a large study of 614 patients who underwent talc poudrage, 7 patients developed adult respiratory distress syndrome and 12 developed REPE. The fluid drained in 11 of 12 patients was >3000 ml.[62] For large pleural effusions, 2 therapeutic thoracentesis are recommended before the procedure with 1000–1500 ml fluid drain in each sitting. There is no evidence of measure/estimate of “safe” amount of fluid which can be aspirated from the pleural space during MT. The general consensus is for the maximum possible removal of fluid for proper visualization of pleura. Slow removal of pleural fluid is advocated to allow for air to replace fluid, keeping pressure equilibrium and avoiding undue rapid negative pressure in the pleural space and lungs.

Consensus statement 14 (ii)

• Maximum possible volume of fluid should be aspirated during thoracoscopy. (UPP)

• The rate of pleural fluid removal should be slow to allow for air entry in the pleural space and avoid major shift in intrapleural pressure and prevent REPE. (UPP)

Q 14: iii: How many pieces of pleural tissue are to be obtained during pleural biopsy?

While obtaining a pleural biopsy, the minimum number required for an appropriate diagnostic yield is to be weighed against the maximum number of biopsies, which can be obtained safely without any complications. Also, there are no meta-analysis/RCTs available on the number of biopsies required for an adequate diagnostic yield without any complications.

Loddenkemper et al.[25] opined that two to six biopsies of a suspicious pleural lesion can help establish the diagnosis. In patients with malignant pleural effusion secondary to carcinoma of the breast or other tumours where hormone receptor studies will be required, sufficient quantities of tissue must be obtained. In patients with undiagnosed pleural effusions, biopsies should be taken from suspicious lesions at the anterior and posterior chest wall and the diaphragm for histological evaluation.[25] Thomas et al.[64] have advocated that the pleural space must be examined thoroughly, and two to four biopsies must be taken from the abnormal lesions on parietal pleura by a lateral “lift and peel” technique. Multiple biopsies (three to six pieces) must be taken if no gross abnormalities are observed and the samples should be sent for histopathology and for culture of Mycobacterium tuberculosis.[64] A number of biopsies (10–12 bits) should be proportionately increased if molecular studies are desired. The additional risk incurred in obtaining more biopsy pieces has not been reported in the literature.

Consensus statement 14 (iii)

• Two to six pieces of pleural biopsy should be taken routinely. However, in case of additional microbiological or molecular studies, more biopsies may be obtained. (UPP)

Q 14: iv: Should specimen be routinely sent in saline and formalin? How many pieces each?

There is no published literature (no prospective study or RCT) available to address this question. Samples in saline are used for microbiological investigations, whereas formalin samples are used for histopathology. In the Indian context, there is a high burden of tuberculosis and tubercular pleural effusion. Tubercular and malignant effusions can mimic each other, and pleural biopsy may be the only differentiating tool. There are anecdotal reports of simultaneous occurrence of TB and tubercular effusion with malignancy or during chemotherapy. So, specimens should be collected in both saline and formalin.

Consensus statement 14 (iv)

• Due to high burden of tubercular pleural disease in India, specimen should be collected in both saline and formalin. (UPP)

• In case of unavailability of adequate specimen for histopathological testing, formalin sample should be prioritized, with fluid or aspirate sent for infectious disease workup. (UPP)

Q 14: v: Is there any benefit of frozen section (rapid onsite examination)

Frozen sections allow for fast and relatively accurate intraprocedural evaluation of biopsy specimens. The biopsy specimen is assessed on site by a pathologist giving rapid results within 10–30 min. It can be used in places where immediate diagnosis can change the course of treatment, e.g. suspected malignant pleural effusion where patients can be planned for thoracoscopic biopsy and pleurodesis in a single sitting. A frozen section can also be used to confirm the adequacy of biopsy specimen, presence or absence of lesion and nature of lesion (malignant or benign). There are limited observational studies documenting a good yield and a high positive predictive value of frozen sections for pleural malignancy.[65,66] One of these observed the utility of frozen section in patients with suspected malignant pleural effusion where simultaneous pleurodesis was planned.[65]

Consensus statement 14 (v)

• Where pleurodesis is anticipated in suspected malignant pleural effusion, frozen section may be utilized if facility is available. (Level-3, Grade A)

• We do not recommend the routine use of frozen section in MT to increase the yield of thoracoscopic pleural biopsy. (UPP)

Q 14: vi: Techniques of pleural biopsy – tearing or pulling

The biopsy of the parietal pleura should be performed over a rib to avoid injury to the neurovascular bundle in intercostal spaces. Biopsy forceps is used to probe the rib and the hard surface. After this, the parietal pleura overlying the rib is grasped and removed with a long tearing motion. Lift and peel technique yields a bigger piece. There are no RCT/prospective studies available comparing various biopsy techniques. Biopsies with the semirigid thoracoscope are small since they are limited by the size of the flexible forceps, which in turn depends on the diameter of the working channel. The standard text on thoracoscopy recommends using a tearing technique over a pulling technique. Bigger pieces can be obtained using this method.

Consensus statement 14 (vi)

• While using forceps, biopsy should be taken with a “lift and peel” or “tearing” technique. (UPP)

Q 14: vii: Should visceral pleural biopsy/lung biopsy be performed during MT?

Visceral pleural biopsy or lung biopsy should not be done routinely. Safety of the procedures under local anaesthesia is not documented.

Consensus statement 14 (vii)

• Visceral pleural biopsy or lung biopsy should not be done by medical thoracoscopists. (UPP)

Q15: Which is the agent of choice for pleurodesis?

Several agents have been advocated for pleurodesis, but significant differences have not been reported between different agents. The agents used include talc, bleomycin, tetracycline, doxycycline, silver nitrate, Sericin, etc.[67,68,69] Talc pleurodesis has been used for several decades. The current data support talc as the most effective agent for pleurodesis. Earlier concerns were raised regarding the development of malignant diseases after topical talc application. However, the emerging evidence indicates that talc pleurodesis with modern, purified-grade salt is safe and highly effective. Talc is an inexpensive and accessible option for pleurodesis.[70] In a meta-analysis of 24 studies, talc pleurodesis was significantly superior to control methods especially compared to bleomycin.[71] There are many studies regarding the use of talc in malignant pleural effusion for achieving pleurodesis. Talc in slurry and povidone iodine have been reported to be equally effective and safe in pleurodesis for symptomatic, recurrent malignant pleural effusion. In lower-income countries, povidone-iodine may be preferred due to its easy availability and low cost. It can be administered through an intercostal drain and repeated if necessary.[72] There is no difference in complication rates and adverse events between the two methods.[73] Both poudrage during MT and slurry via the chest tube are equally effective in producing pleurodesis and do not alter the disease progression. Poudrage during MT has been shown to reduce the recurrence of effusion, reduce hospital stay postprocedure as well as the chest tube in situ. Instillation of slurry via the chest tube has shown to increase pain and fever for the patient when compared to poudrage during MT.[9]

Consensus statement 15

• Thoracoscopic talc pleurodesis should be considered as an option for the management of malignant pleural effusion at the time of MT if malignancy is strongly suspected. (Level 1, Grade A)

• Sterile graded talc is the ideal best agent for chemical pleurodesis. (Level 3, Grade B)

Q 16. What should be the air circulation in a thoracoscopy suite?

MT is often performed in operation theatres or in bronchoscopy rooms or dedicated endoscopy suites. Bronchoscopy room is recommended to have a minimum of 12–15 fresh air exchanges per hour with the direction of airflow from the room entrance to the back and outside. If recirculation of air is unavoidable, the direction of exhaust air being thrown out should be away from patientcare areas, and highefficiency particulate air (HEPA) filters must be used.[36]

The Indian guidelines issued by the Ministry of Health and Family Welfare state that bronchoscopy suites should have at least 15 air exchanges per hour, with directional air flow along with local exhaust ventilation, and air exhausted at least 2 m from any open window. Utilization of air cleaning methods such as ultraviolet germicidal irradiation or HEPA filtration has also been suggested subject to availability.[74]

Consensus statement 16

• We recommend 12–15 fresh air exchanges per hour for the thoracoscopy suite. (Level 3; Grade A)

• Medical thoracoscopy should ideally be performed in a room with a negative pressure design. (UPP)

• In absence of adequate air circulation, direct air exhaust with HEPA filter directed away from patient care area may be used. (UPP)

Q 17: Is routine oxygen supplementation necessary in patients undergoing MT?

During routine MT in patients with initially normal arterial oxygen saturation, no significant changes are observed in the oxygen saturation and cardiac rhythm during the procedure. MT had been conducted in patients with mild hypoxemia (PaO_2: 50–60 mm Hg) and/or hypercapnia (PaCO_2: 45–60 mm Hg), and no serious side effects were observed. None of the patients required early termination of the procedure.[75] Oxygen 3 L/min via nasal cannula was administered during the entire procedure to prevent cardiac arrhythmias, hypotension and hypoxemia.

Several causes of hypoxia during MT have been postulated. [Table 5]

Table 5.

Causes of hypoxia

1.	Depression due to the anesthesia (more hypotension and hypoxemia were seen with the use of propofol),
2.	lung,
3.	Induced pneumothorax,
4.	Underlying pulmonary disease,
5.	Splinting from postprocedural pain,
6.	Potential effects of interventions like talc poudrage

Consensus statement 17

• Supplemental oxygen can be administered to the patients undergoing MT with a target oxygen saturation above 90%. (Level 3, Grade A)

Q 18: When should the ICD be removed post-MT?

The chest drain can be removed when drainage is less than 50–100 ml with complete radiological expansion of the lung and no air leak. A survey of Indian chest physicians performing MT indicated that post-thoracoscopy, the chest drain was removed by most of the respondents after lung expansion on the same day (23.2%), or the next day (59.6%). In patients with nonexpanding lungs following thoracoscopy, 67% were discharged with intercostal tube and 11.3% would consider the insertion of an indwelling pleural catheter.[36]

The removal of the chest drain depends on the underlying aetiology of the pleural effusion. If malignancy is suspected and TALC poudrage is not performed, then waiting for the histopathology confirmation to plan pleurodesis would be advisable. However, if the aetiology is nonmalignant, then general principles of lung expansion and no air leak are ensured before removing the chest drain. In most cases, total resolution of the pneumothorax occurs within minutes. After a chest radiograph confirms the re-expansion of the lung, the chest tube is often removed while the patient is still in the procedure room.

Consensus recommendation: 18

• We recommend the chest drain to be removed early as soon as lung is fully re-expanded radiologically with drain less than 50–100 ml over 24 h and no evidence of air leak. (Level 3, Grade A)

Q 19: Should a second port be used in MT?

Two-port thoracoscopy is reserved for selected conditions and is not routinely performed. Double-port access may be necessary to evaluate the pleural space completely when the rigid telescope is used, especially if the posterior and mediastinal aspects of the hemithorax are inaccessible because of the partial collapse of the lung or when the lung parenchyma is adherent to the chest wall [Table 6]. Some operators routinely use a second entry port as it improves the visualization of the pleural space.[76] The second port should be in line with the first and should be separated from it by about one to two intercostal spaces. Double ports have been used for pleural decortication in chronic empyema, to facilitate adhesiolysis, control bleeding, perform pleurodesis or for bulla electrocoagulation. A double-port method is usually performed under general anaesthesia. A 5-mm trocar is typically used for the second port as the flex–rigid scope has a 7-mm outer diameter.[9]

Table 6.

Indications for a second port

Need for a second port:
• To drain complex loculated fluid collections,
• To facilitate adhesiolysis,
• To obtain larger pleural biopsies,
• For ‘‘pinch’’ lung biopsy,
• For sampling abnormal lesions around the first entry site, and
• To control bleeding.

Q 20. How can the risk of REPE be reduced post-MT?

REPE is a rare but potentially fatal complication in the treatment of pneumothorax, haemothorax and pleural effusion.[77] The reported incidence of REPE following drainage of pleural effusion and pneumothorax has been reported to be between 0% and 1% in most studies.[78] The pathogenesis of REPE remains unclear. The evidence regarding REPE following MT is sparse.

Patients with REPE have symptoms such as chest discomfort, persistent severe cough, production of frothy sputum and dyspnoea. The onset of symptoms is often within 24 h, with 64% of patients having onset within 1–2 h after lung re-expansion.[78,79,80] The cardinal signs are tachypnoea, tachycardia and crackles on the affected side of the lung and hypoxemia, which could be refractory to oxygen therapy. The oedema affects the entire re-expanded lung or it may affect a single lobe or the contralateral lung, or it may be a bilateral process.[80] A chest radiograph is usually diagnostic.[78] Recovery often occurs completely in most patients within five to seven days. However, severe REPE could result in sequestration of large amounts of fluid in the lung, leading to shock and possibly death.[77,79,80,81] Proposed risk factors include age between 20 and 40 years, diabetes, duration of collapse greater than 72 h, the application of high negative pressures during thoracic drainage (>20 cm H₂O) and rapid lung expansion with drainage of large volumes of pleural fluid.[77,78,79,82]

Consensus statement 20

• We suggest avoiding rapid drainage of pleural fluid and application of excessive suction to prevent REPE. (UPP)

• We suggest removal of fluid prior to MT in patients with massive pleural effusion to avoid REPE. (UPP)

Q 21: MT – Postprocedure care and management – Role of systematic suctioning and drainage

There is no evidence regarding the application of systematic suction following MT. Among patients undergoing VATS and lung resection, the application of suction has shown conflicting results in terms of air leak, duration of chest tube and hospital stay. Postprocedure care includes management of pain, looking for infection at site, functioning of the drainage bottle and postprocedural analgesia. Acetaminophen, nonsteroid anti-inflammatory drugs and opioids can be used for this purpose.

Consensus statement 21

• Routine application of suction after MT is not recommended. (UPP)

• Postprocedural monitoring of vital parameters such as body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and pleural fluid drainage is recommended. (UPP)

• Postprocedural analgesia should be individualized based on the patient’s needs. (UPP)

Q 22: Can MT be performed as a daycare procedure?

MT has long been performed as an in-patient procedure with patients being admitted at least a day prior to the procedure. In recent years, there has been a trend of an increasing number of procedures being performed on daycare basis. The practice of keeping patients admitted post-procedure was highly variable from centre to centre and region to region.[36,83,84,85] There is no study that directly compares the complication rate or hospital readmission rates of patients undergoing MT as in-patient procedure versus daycare procedure. There are several descriptive studies describing MT being performed as a daycare procedure. Three of those studies had a complication rate of less than 5%. The most commonly observed complications were pain at the port site, mild ooze, subcutaneous emphysema, vasovagal reactions and late pleural infections.[85,86,87,88,89] One retrospective study of patients undergoing MT as a daycare procedure by Kyskan et al.[87] showed a hospital readmission rate of 0.9%. Two studies reported complication rates of 11% and 20% in patients who underwent thoracoscopy on daycare basis.[87,88] However, there were no deaths in both the studies and the sample size in one of these studies was very small.[88] The reported rate of repeat pleural intervention during MT as a daycare procedure is less than 12%.[85,86,87,88,89]

Consensus statement 22

• Medical thoracoscopy can be performed as an outpatient procedure. (Level 2, Grade A)

Q 23: Practice to perform chest radiograph routinely post-thoracoscopy and duration to monitor postprocedure

Reports have challenged the utility of empiric postoperative chest radiograph in thoracic surgery, but evidence-based guidelines to restrict their use are lacking.[90] Postprocedure routine chest radiographs have a limited clinical impact on further decision making.[90] We could extract one study by Kyskan et al.[87] 2017 who performed postprocedural chest X-rays immediately off suction and 2 h after to confirm lung re-expansion. Discharge criteria included observation for at least 2 h, adequate pain and nausea control, oxygen saturations being returned to baseline or improved, hemodynamic stability, and absence of pneumothorax or stable pneumothorax on 2-h postprocedure chest X-ray. After 2 h of observation, patients without significant complications were discharged with oral analgesic.

Consensus statement 23

• Chest radiograph may be routinely performed following MT to document lung expansion, confirm the position of chest tube and exclude left out foreign bodies. (UPP)

• Patients undergoing MT should be kept under observation postprocedure, minimum till the effect of sedative medication weans off. (UPP)

• Discharge protocols should be in accordance with the local practices for daycare procedures. (UPP)

Q 24: Counselling for rigid and semirigid thoracoscopy

There is no study evaluating the role of counselling in rigid or semirigid thoracoscopy. As a universal good practice point, counselling and informed consent is a mandatory part of preoperative workup. Informed consent is accompanied by providing entire procedure-related information to the patient and caregivers. The final choice of the procedure should be individualized based on indication, experience of the operator and general condition of the patient.

Consensus statement 24

• Although evidence is lacking regarding the role of counselling in patients undergoing MT, counselling must be an integral part of consenting process. (UPP)

• Counselling for rigid or semirigid thoracoscopy must be based on indication, availability of the equipment, experience of the operator and general condition of the patient. (UPP)

Q 25: How can rigid and semirigid thoracoscopes be disinfected?

The agents for thoracoscope disinfection include alkylating agents such as glutaraldehyde, orthophthaldehyde (OPA) and glutaraldehyde with isopropyl alcohol. [Table 7] Oxidizing agents which can be used for disinfection include hydrogen peroxide, peracetic acid (PAA), chlorine-based agents, argon plasma-activated gas and sequential washing with electrolyzed alkaline and acidic water.

Table 7.

Disinfection of Thoracoscopes

Glutaraldehyde	Orthophthaldehyde	Peracetic acid
Cheap, noncorrosive	More effective than glutaraldehyde at a lesser concentration	0.25% PAA is effective against mycobacteria, including atypical mycobacteria at a contact time of 5 min
2% glutaraldehyde solution effective against MTB with contact time of 20 min	0.5% orthophthaldehyde has superior mycobactericidal activity at a contact time of 5 min	Has corrosive action on metals
Has a pungent odour	Causes staining of endoscopes and remains adherent to the scope despite rinsing and may lead to allergy and anaphylaxis	Safe but expensive

In the study by Fraser et al.,[91] annually disinfected endoscopes were contaminated with coliform bacteria, while endoscopes that underwent automated disinfection were contaminated with nontuberculous mycobacteria, but the differences were not statistically significant. The air and water channels are at risk of contamination. The brushing of every channel is mandatory to achieve a high-level disinfection.[92]

Consensus statement 25

• Glutaraldehyde (2%) and OPA (0.5%) can be used as alternative disinfectant agents with contact time of 20 and 5 min, respectively. (UPP)

• Disinfection of semirigid thoracoscope may be performed either manually or using in automated thoracoscope reprocessor (AER). (Level 3, Grade A)

• If resources permit, AER is preferred over manual disinfection in view of better safety profile to healthcare staff and patients. (Level 3, Grade A)

• Working channel brushing should be done regularly after every procedure so that cross-contamination is avoided. (Level 3, Grade A)

Q 26: Is bacterial surveillance required? How often should bacterial surveillance be performed?

The MT suite must have a quality assurance programme with regular microbiological surveillance. The team of the pulmonologist, nurses and microbiologists should cooperate in sample collection and should have agreed to the predecided test schedules and sampling plan. Collection of samples for surveillance must be done under strict aseptic precautions from all channels and the outer surfaces of thoracoscopes.[93,94] Maintenance of thoracoscopes should be in accordance with the manufacturer’s instructions. Guidelines recommend routine testing at intervals not longer than 3 months. The tap water used for cleaning and air samples should also undergo microbiological surveillance.

Consensus statement 26

• Microbiological sampling of thoracoscopes should be performed. (Level 3, Grade A)

• We recommend microbiological surveillance every 4 weeks. (UPP)

Q 27. How should the thoracoscope be stored?

Storage of many flexible endoscopes is not an issue since they are routinely used and rarely remain idle for more than a day. A proper storage environment protects the endoscope from damage and minimizes environmental contamination.[95] Drying is a critical element in reprocessing. Moisture allows microorganisms to survive and multiply; therefore, all channels and the surface of the endoscope must be thoroughly dried before storage.[95]

Schmelzer et al.[96] recommended that endoscopes can be stored for 7 days if they have been effectively reprocessed to remove all microorganisms and are stored in a completely dry state and free from environmental and human contamination. A 7-day storage interval for reprocessed endoscopes is recommended but only if they were reprocessed and stored according to professional guidelines and manufacturer’s instructions.[97]

Consensus statement 27

• Thoracoscopes must be completely dry to avoid risk of recontamination and development of biofilms. (UPP)

• Flushing of thoracoscope channels with 70–90% ethyl or isopropyl alcohol followed by forced air drying is recommended. (UPP)

• Store thoracoscopes in a freely hanging vertical position. (UPP)

• Thoracoscopes should be stored in a closed cabinet to prevent contamination from water droplets. (UPP)

• Do not store thoracoscopes in shipment cases. (UPP)

• Semirigid thoracoscopes should be stored with all valves open, and removable parts should be detached but stored with the scope. (UPP)

• Semirigid thoracoscopes should be clearly identifiable, processed and ready for use. (UPP)

• Mark thoracoscopes with an obvious visual cue to enable healthcare workers to easily distinguish clean and dirty thoracoscopes. (UPP)

• Flexible thoracoscopes may be dried in AERs, manually, or in drying/storage cabinets. (UPP)

Storage cabinet:

• Flexible thoracoscopes that have been mechanically processed should be stored in a cabinet that is either:

  • (i)
    designed and intended by the cabinet manufacturer for horizontal storage of flexible thoracoscopes, or
  • (ii)
    of sufficient height, width and depth to allow a flexible thoracoscope to hang vertically without coiling and without touching the bottom of the cabinet. (UPP)

• Should be situated in a secure location in a separate clean workroom of the endoscopy processing area. (UPP)

• Should have doors and should be located at least 3 feet from any sink. (UPP)

• Ideally, cabinets should have HEPA-filtered air that provides positive pressure and allows air circulation around the flexible thoracoscopes. (UPP)

Q 28: Where to keep the patient postoperative for monitoring and patient follow-up strategy?

After MT, monitoring of the patient’s vital parameters such as respiratory rate, temperature, pulse, blood pressure, oxygen saturation and pleural fluid drainage is recommended. This must be recorded every 15 min for the first hour after local anaesthetic thoracoscopy.[79] There is no data available to suggest where the patient should be kept for monitoring after MT, so the patients should be monitored in the recovery rooms for at least 1 h after the procedure.

Consensus statement 28

• Patients should be monitored in the recovery room for at least 1 h after thoracoscopy. (UPP)

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

SUPPLEMENTARY ANNEXURE 1: (CONSENT PROFORMA)

• The patient’s full name and medical record number/ward number/identification number/HMIS ID should be recorded foremost in the consent form.

• The patient and family member/relative/guardian should be given information about the condition and the reason for recommending medical thoracoscopy (MT) procedure.

• The information sheetis annexed in the Supplementary files (Annexure 1) should be given well in advance to the patient and relatives to understand the procedure.

• The consent form should be further elaborated in the patient’s own words to provide a written confirmation of these discussions.

• Preferably, the patient or his/her relative should write consent with their own hands in their own language, as far as possible.

I________________________S/D/W/H of ___________________________________ hereby state that I have been explained the needs, and benefits of the MT procedure, by the doctor in the language, I can understand. I give my full and free consent for this procedure of MT.

The doctor has explained that you have the following condition:

………………………………………………………………………………………………

To diagnose your disease, as per the evaluation protocol-

You will undergo a procedure named MT to obtain pleural tissue for pathological examination. However, it will be your choice to undergo any of these procedures for further evaluation of your disease. Without your valid consent, the procedure will not be performed on you. At any point of time prior, you can withdraw yourself from this procedure. This will not affect your further treatment and management. However, a documentation of the same will be done.

I acknowledge that the doctor has explained:

• My medical condition and the proposed procedure, including additional treatment if the doctor finds something unexpected. I understand the risks, including the risk of anaesthetic medications required for this procedure.

• Other relevant procedure/treatment options and their associated risks.

• My prognosis and the risks of not having the procedure.

• I am also aware of the following:

  • Nature of anaesthesia needed.

  • The potential benefits of the procedure.

  • The likely result if I do not have the recommended procedure/intervention and done.

  • The available alternative treatments and their benefits and risks.

• That no guarantee has been made that the procedure will improve my condition even though it has been carried out with utmost professional care.

• Tissues and blood may be removed and could be used for diagnosis or management of my condition, stored and disposed of as per hospital and protocols.

• If immediate life-threatening events happen during the procedure, they will be treated based on my discussions with the doctor or my Acute Resuscitation Team.

• A doctor other than the consultant may help and conduct the procedure, I understand this could be a doctor undergoing further training.

• I was able to ask questions and raise concerns with the doctor about my condition, the proposed procedure and its risks and my treatment options. My questions and concerns have been discussed and answered to my satisfaction.

• I understand I have the right to change my mind at any time, including after I have signed this form but, preferably following a discussion with my doctor, I understand that image/s or video footage may be recorded as part of and during my procedure and that these image/s or video/s will assist the doctor to provide appropriate treatment.

• I voluntarily consent to the performance of the procedure/intervention/anaesthesia (if any) described above by my clinician or those who work with him/her.

Name of patient: Age/Sex:

Self/Relationship:

Ins.no. UHID/Registration no.

Phone no.

Signature of patient: Signature of relative

PATIENT INFORMATION SHEET

MEDICAL THORACOSCOPY

1. What is a MT?

   A thoracoscopy is an examination of the space between your lung and chest wall. The doctor uses a thin tube (pleuroscope) which is placed through the skin of your chest into the space between the lung and ribs (pleural space). This is to find the cause of fluid or air in the pleural space.

   You will have the following procedure:

   You will lie on your side during the procedure and have a rolled-up towel placed beneath your ribs. You may have a sedative drug injected into your vein to relax you. Sometimes you will not remember having the thoracoscopy because of the sedative.

   The doctor injects local anaesthetic into the skin and then into the muscle between your ribs. The doctor will make a small cut in the skin, and then place a hollow tube though this cut into the space between the lung and ribs (pleural space). Sometimes a second cut may be needed.

   The doctor will then insert a telescopic instrument through the hollow tube. The doctor will use this instrument to look around the pleural space or obtain pleural biopsies by removing small pieces of the lining of the pleural space. This may cause some pain. Pain relief may be injected into your vein before the biopsies are taken to reduce this pain.

   The procedure does not stop your normal breathing. Often your breathing may feel more comfortable during the procedure after the fluid in the pleural space is removed. At the end of the procedure, you will have a chest tube coming out of the same incision. This drains any air or fluid from your pleural space.

2. What are the risks of this specific procedure?

   In recommending this procedure your doctor has balanced the benefits and risks of the procedure against the benefits and risks of not doing the procedure. Your doctor believes that there is an overall benefit for you in going ahead with the procedure.

3. There are risks and complications with this procedure. They include but are not limited to the following:

   1. Common risks and complications (more than 5%) include:

      • Chest pain. The nerves between the ribs are bruised after the procedure, which can cause some persistent pain. This may be controlled with paracetamol.

      • Fever. The fever goes away in a few days.

      • Increased risk in obese people of wound infection, chest infection, heart and lung complications and thrombosis.

   2. Uncommon risks and complications (1–5%) include:

      • Air leak from the lung. A small hole develops in the lung. This means the chest tube has to stay in longer.

   3. Rare risks and complications (less than 1%) include:

      • Infection. A small chest tube will be put into the pleural space to drain out the infection. This will need antibiotics.

      • Bleeding. This can happen after biopsies. Usually, it is minor and settles quickly. Bleeding is more common if you have been taking blood-thinning drugs such as warfarin, aspirin, clopidogrel.

      • Heart problems. A brief minor strain may be put on the heart. This can cause abnormal beating of the heart, fluid to accumulate in the lungs, a heart attack or the heart may stop beating.

      • Low oxygen levels. You will be given oxygen.

      • Death as a result of this procedure is rare.

4. Before the procedure

   • You must not eat or drink anything for at least six hours before the procedure.

   • Bring your papers, X-rays or CT scans with you.

   • You will be hospitalised for the procedure. The stay will depend on your general health. Minimum a 24-h stay will be needed if there are no complications.

5. After the procedure

   • The chest tube may have to remain in your body for a few days.

   • The chest tube causes some pain. Some pain-relieving drugs are sometimes needed.

   • After you are discharged from hospital, you will need stitches to be removed from your wound. You may rarely be discharged with an ambulatory chest drain.

6. You must contact the hospital if you have:

   • Fever that does not go away.

   • Ooze/discharge from the wound.

   • If you have shortness of breath.