Endoscopic ultrasound in the management of acute cholecystitis: Practical review

Abstract

Endoscopic ultrasound‐guided gallbladder drainage (EUS‐GBD) has emerged over the last years as an alternative procedure to percutaneous drainage (PT)‐GBD in patients with acute cholecystitis (AC) at high surgical risk. This process has been driven by the advent of lumen‐apposing metal stents (LAMS) with electrocautery‐enhanced capability, which has rendered the drainage procedure easier to accomplish and safer. Studies and meta‐analyses have proven the superiority of EUS‐GBD over PT‐GBD in high‐surgical‐risk patients with AC. Little evidence exists in the same setting that EUS‐GBD compares equally with laparoscopic cholecystectomy (LC). Moreover, EUS‐GBD might theoretically have a possible role in patients at high surgical risk with an indication to undergo cholecystectomy or with a high probability of conversion from LC to open cholecystectomy. Properly designed studies are needed to better clarify the role of EUS‐GBD in these patient populations.

INTRODUCTION

Laparoscopic cholecystectomy (LC) represents the treatment of choice for patients with acute cholecystitis (AC). ¹ There is, however, a subset of AC patients with underlying severe comorbidities for whom surgery is not an option, and in whom percutaneous gallbladder drainage (PT‐GBD) has been traditionally employed to treat this condition.

The updated 2018 Tokyo guidelines underlined the role of PT‐GBD as a primary intervention for the management of AC in high‐surgical‐risk patients. ² Some patients, however, require indefinite maintenance of the cholecystostomy drain, with a necessity for reintervention in up to 66% of cases with a negative effect on their quality of life. ³ , ⁴ Moreover, contraindications to PT‐GBD, such as ascites, may exist. Therefore, endoscopic ultrasound (EUS)‐guided GBD has emerged as an alternative procedure to overcome some of the limitations of the percutaneous approach. This change has been facilitated by the development of electrocautery‐enhanced lumen‐apposing metal stents (EC‐LAMS), which permit creation of a stable fistula between the gastrointestinal (GI) lumen and the gallbladder in a one‐step procedure, decreasing the occurrence of adverse events (AEs). ²

In this review, absolute and possible indications and contraindications (Table 1) to perform EUS‐GBD in patients with AC, along with data on procedural and long‐term AEs and outcomes of the procedure, will be presented through cases showing different clinical scenarios.

Table 1.

Indications and contraindications for performing endoscopic ultrasound‐guided gallbladder drainage (EUS‐GBD)

Indications for EUS‐GBD

Patients with acute cholecystitis at high risk for cholecystectomy 2

Patients in whom PT‐GBD has been performed in whom conversion of the long‐term percutaneous cholecystostomy to internal drainage is desired 5

Contraindications to EUS‐GBD 6

Evidence of gallbladder perforation or biliary peritonitis

Patients who cannot tolerate deep sedation or anesthesia †

Lack of expertise or of adequate training

The usage of LAMS should be avoided in the gangrenous gallbladder ‡ , 7

Need for postprocedural cholecystectomy with a less experienced surgeon available §

Gallbladder not sufficiently dilated or in case large or the presence of multiple stones preventing distal flange release, when LAMS placement will be challenging or even impossible

Large ascites ¶

Coagulopathy or anticoagulation use which cannot be discontinued

^† In these cases, percutaneous gallbladder drainage (PT‐GBD) can be performed under local anesthesia with only or even without minimal sedation.

^‡ In case of doubt, an abdominal computed tomography scan should be performed to assess the vascularity of the gallbladder and to rule out perforation. ⁸

^§ PT‐GBD could be preferred in this case, since it does not compromise the local anatomy, thus allowing easier laparoscopic cholecystectomy after recovery from cholecystitis and after optimization of the status of the underlying comorbidities.

^¶ Ascites can be drained preprocedurally, thus allowing EUS‐GBD.

LAMS, lumen‐apposing metal stent.

History of the technique for EUS‐GBD

Endoscopic ultrasound‐guided GBD was first described 15 years ago by Baron and Topazian, ⁹ who achieved drainage using a double pigtail plastic stent (DPPS). Since then, multiple refinements of the technique and development of dedicated stents have rendered the procedure easier and safer. ¹⁰

Double pigtail plastic stents are unable to completely seal the newly created fistulous tract, with an intrinsic increased risk for AEs, especially bile leak. As a consequence, their use has been largely abandoned in recent years. In the last decade, reports and studies on the feasibility and efficacy of metal stents for EUS‐GBD have been published. The first utilized stents were fully covered self‐expandable metal stents (SEMS) originally intended for common bile duct drainage, which however were associated with an increased risk of migration. ¹¹ The use of modified SEMS with antimigration features or specifically designed biflanged SEMS decreased migration occurrence and appeared to have advantages over DPPSs because of their larger caliber and capability to offer immediate sealing of the transmural fistulous tract by stent expansion. ¹² , ¹³ Their major limitation is their length, with long ends potentially causing mucosal injuries resulting in ulceration, bleeding, or stent embedding.

The advent of LAMS, fully covered and with bilateral flanges specifically designed for robust lumen anchorage, surpassed the limitations of SEMS. ¹⁴ An additional advantage is the diameter of the saddle portion, which creates an easy‐to‐use port of entry for intracholecystic interventions. ¹⁵ Finally, the addition of a cystotome capability on the tip of the device rendered EUS‐GBD a one‐step procedure, reducing the risk of failure related to multiple accessory exchanges. ¹⁶ The EC‐LAMS do not necessarily require prior needle puncture and guidewire insertion, making it possible to perform EUS‐GBD at the bedside in very sick patients in the intensive care unit, without X‐ray guidance. ¹⁷ , ¹⁸ In view of the increased safety profile and high success rates, LAMS are now recommended as the stents of choice for EUS‐GBD by the recently published European Society of Gastrointestinal Endoscopy (ESGE) guidelines. ¹⁹ , ²⁰

Despite all of the above‐described technical advancements, EUS‐GBD remains challenging and AEs such as stent misplacement with perforation or stent migration can occur even in skilled and experienced endosonographers' hands. ¹

Procedural technical aspects

Endoscopic ultrasound‐guided GBD in AC patients is accomplished by transmural placement of a stent from the lumen of the stomach or duodenum into the gallbladder. The fistulous tract is created from the distal antrum or the first portion of the duodenum. Once interposing vessels are excluded and the two luminal structures (gallbladder and the GI tract) are located within a 10–20 mm distance, the “indirect access” method can be utilized, where the gallbladder is first penetrated with a 19G fine needle aspiration (FNA) needle, allowing placement of a guidewire to further guide insertion of multiple accessories for tract dilation and stent placement. For the “direct access” method, the gallbladder is accessed freehand with a cautery‐enhanced all‐in‐one delivery device through which the LAMS is finally placed. The latter technique is favored by most experts, since it avoids accessories exchange and makes the procedure easier and safer to accomplish.

With the last generation of EC‐LAMS, fistulous tract creation is accomplished with pure cutting current using the built‐in cautery device for stent insertion (AutoCut mode 100 W, effect 5 for an ERBE generator). Following penetration into the gallbladder lumen, advancement of the cautery device is needed in order to allow the proper space for uneventful stent deployment. The distal flange is opened first and then pulled back until a change in its shape from flat to oval occurs, all done under EUS guidance. Release of the proximal flange can at this point be done safely, under endoscopic control after visualization of the proper marker on the device catheter, or inside the EUS working channel followed by slow endoscope withdrawal, allowing for its full deployment under EUS control. Adequate stent position should be confirmed at the end of the procedure.

The technique in case of a gallbladder of reduced size is more challenging. This situation can be encountered also in cases of internalization of a previously external drain, when the gallbladder is frequently contracted, with thickened walls, and a reduced lumen. In such cases, if in place, the percutaneous drainage should be closed 1 day before the procedure, while if more distension of the gallbladder is needed, injection of saline with or without contrast through the percutaneous drain or by using an EUS‐guided FNA needle can be done until the necessary gallbladder diameter is reached (Fig. 1). ⁸

Figure 1.

Endoscopic ultrasound (EUS)‐guided gallbladder drainage in the case of a small diameter gallbladder. (a) Puncture with a 19G EUS‐fine aspiration needle for saline injection. (b) Obtainment of a larger gallbladder dimension. (c) EUS‐guided gallbladder puncture with the cautery device, (d) followed by stent deployment.

Anticoagulants and/or antiplatelet drugs should be discontinued preprocedurally, if possible, ²¹ , ²² while the availability of surgeons and interventional radiologists with expertise in hepatobiliary diseases is mandatory for performing EUS‐GBD. ²⁰

Definition of a high surgical risk patient

The 2018 Tokyo guidelines stated that EUS‐GBD represents a valid alternative to PT‐GBD in patients with AC unfit for surgical intervention in centers with appropriate endoscopic expertise, ² while the recently issued ESGE guideline favors EUS‐GBD over the percutaneous route. ²³ However, no clear‐cut consensus on how to define a patient as being at high risk for surgery exists. In some studies, the Simplified Acute Physiology Score II (SAPS II) of ≥15, while in others APACHE II (Acute Physiology Assessment and Chronic Health Evaluation II) score of ≥7 were used to define patients at high risk; more recently, an American Society of Anesthesiologists score over 3 or 4 was used for the same purpose. ²⁴

The best strategy for possible gallbladder drainage candidates should always be discussed and decided in multidisciplinary meetings involving at least surgeons, anesthesiologists, interventional gastroenterologists, and radiologists, after a thorough review of the clinical history, comorbidities, and risks of anesthesia and surgical interventions.

CLINICAL SCENARIOS

Case No. 1. Female patient with multiple organ dysfunction syndrome, temporarily considered not a surgical candidate

A 65‐year‐old woman with a history of hypertension well controlled with medication and hypercholesterolemia, presented with right abdominal pain for a few days. Laboratory tests revealed a white blood count of 25,000/μL, C‐reactive protein of 251 mg/dL, and serum creatinine of 3.2 mg/dL. Her blood pressure was 70/40 mmHg and noradrenaline support was needed. Abdominal ultrasound showed thickening of the gallbladder walls (6.5 mm), with multiple gallstones and pericholecystic fluid. The patient received fluid resuscitation and intravenous antibiotics and was temporally considered a nonsurgical candidate. The multidisciplinary discussion decided for percutaneous drainage placement.

In this clinical picture, the patient was not surgically fit at the moment of the evaluation, but will most likely become a surgical candidate after septic shock resolution. The best choice, in this case, is percutaneous drainage followed by LC when the acute phase is resolved. In this setting, EUS‐GBD obtained by placing a nasobiliary catheter in the gallbladder has been reported in a randomized controlled study from Korea to have a performance comparable to PT‐GBD, with significantly less pain. Twenty‐three out of the 29 patients who underwent EUS‐GBD subsequently had LC, with conversion to open surgery in only two of them. ²⁵

Endoscopic ultrasound‐guided GBD requiring moderate to deep sedation could be a burden for patients with high risk, compared with PT‐GBD requiring only local anesthesia. However, data on EUS‐GBD as a bridge to surgery are limited and, once decided, the transgastric is preferred over the transduodenal approach because it allows for an easier surgical repair once the stent is removed. However, the only available study comparing the capability of performing cholecystectomy after EUS‐GBD or percutaneous drainage reported surgical intervention to be possible in all patients, with a conversion rate of 15%, even though it was not clear if EUS‐GBD was performed transgastrically or transduodenally. ²⁶ The risk of a buried stent when LAMS is placed transgastrically can be minimalized by early surgery (within 1 month). Besides, closure of the fistulous tract can be performed either endoscopically after LAMS removal, or intraoperatively by the surgeon, either by standard suturing or by using staplers.

Case No. 2. Elderly patient with multiple comorbidities with severe acute calculous cholecystitis

A 75‐year‐old woman with a history of ischemic heart failure with three coronary stents placed a year before, diabetes, and a previous episode of stroke with complete recovery of the overall functionality, presented with severe acute calculous cholecystitis. An abdominal computed tomography scan showed an enlarged gallbladder, with walls thickened and possibly stones inside, but without evidence of gangrene. After a multidisciplinary discussion, EUS‐GBD was considered the most suited intervention. The procedure was performed with a 15 mm caliber EC‐LAMS placed transduodenally, tailored to the size of the biliary stones, which were 16–17 mm in size. The procedure went uneventfully, resulting in resolution of the AC. Four weeks afterward, cholecystoscopy was done and holmium laser lithotripsy was performed until all stones were extracted. LAMS was removed and exchanged for a 7F DPPS.

In this high‐surgical‐risk AC patient, recent evidence favors EUS‐GBD over PT‐GBD as a definitive treatment. A meta‐analysis by Luk et al. ²⁷ including five studies and 495 patients, found no differences in technical (odds ratio [OR] 0.43; 95% confidence interval [CI] 0.12–1.58; P = 0.21), clinical success (OR 1.07; 95% CI 0.36–3.16; P = 0.90) and mortality rates between EUS‐GBD and PT‐GBD. There were significantly fewer reported AEs for EUS‐GBD (OR 0.43; 95% CI 0.18–1.00; P = 0.05), as well as a shorter hospital stay (pooled standard mean difference of −2.53 days; 95% CI –4.28 to −0.78; P = 0.005), along with significantly lower reinterventions than in the percutaneous drainage group (OR 0.16; 95% CI 0.04–0.42; P < 0.001). Subgroup analysis on patients in whom EC‐LAMS were used yielded similar results. ²⁷

In a recent randomized controlled trial, PT‐GBD was compared to EUS‐GBD, with the primary outcome of a 1‐year AE rate. ²⁸ Among the 80 enrolled patients, in the EUS‐GBD arm there were significantly fewer AEs at 30 days (13% vs. 48%, P = 0.01) and 1 year (26% vs. 78%, P < 0.001). In this group, there were also fewer reinterventions (3% vs. 30%, P = 0.001), unplanned readmissions (15% vs. 50%, P = 0.002), as well as episodes of recurrent cholecystitis (3% vs. 20%, P = 0.029). Moreover, EUS‐GBD was associated with lower postprocedural pain scores and fewer analgesic requirements (P = 0.034). The technical and clinical success and 30 day mortality rates were statistically similar between the two study arms. ²⁸

Based on the above‐presented data, the ESGE guideline on therapeutic EUS recommended performing EUS‐GBD instead of PT‐GBD in patients at high surgical risk, in centers where both techniques are available. ²³

Regarding long‐term EUS‐GBD outcomes, ¹³ late AEs have been reported in 7.1% of cases, including asymptomatic distal stent migration and recurrent AC due to stent occlusion, successfully treated endoscopically in all cases. During follow‐up, the median stent patency time was 458 days, while 96.4% of the patients had no AC recurrence. In another study, recurrent AC or cholangitis was observed in up to 8% of cases, ²⁹ mostly related to either buried LAMS or stent obstruction. In the latter case, the stent can be easily endoscopically disobstructed. The LAMS diameter should be tailored based on the size of gallstones to prevent stent obstruction. In this patient with many comorbities in case of large stones, DPPS could be placed to decrease the risk of stent impaction.

Positioning of the LAMS in the gastric antrum is generally considered at higher risk for food impaction and stent dysfunction. Placement of a coaxial DPPS may decrease the risk of stent occlusion and is favored by the ESGE guidelines. ²⁰ Various calibers of plastic stents, from 7F to 10F have been used so far in this context. However, the evidence behind this recommendation is limited, since in the meta‐analysis by Luk et al., ²⁷ two studies compared procedural outcomes depending on the route of EUS‐GBD (transgastric or transduodenal), ³⁰ , ³¹ with no difference in terms of technical success and AE rates.

Case No. 3. Patient with malignant hilar stenosis involving the cystic duct and a distended infected gallbladder

A 57‐year‐old man with Bismuth IV hilar malignant stenosis presented with jaundice and a distended infected gallbladder with thickened walls most likely caused by tumoral invasion of the cystic duct. Endoscopic retrograde cholangiopancreatography (ERCP) was performed with an inability to cannulate the cystic duct, despite multiple attempts. Two metal stents were inserted to drain the main biliary branches. The procedure was followed by a successful EUS‐GBD performed in the same endoscopic session.

Endoscopic transpapillary gallbladder drainage (ET‐GBD) was first reported by Kozarek ³² 39 years ago as an alternative method for internal gallbladder drainage. The procedure is technically demanding, implying a standard ERCP cannulation of the papilla, selective cannulation of the cystic duct, bypassing the site of obstruction, and final placement of a transpapillary long DPPS into the gallbladder for its decompression. Apart from acute ERCP‐related pancreatitis and postsphincterotomy bleeding, its complication risks include cystic duct perforation. ³³

In the most recent meta‐analysis including five studies with a total of 857 patients, EUS‐GBD (259 patients) was compared with ET‐GBD (598 patients). ³⁴ Overall, EUS‐GBD significantly outperformed ET‐GBD in terms of technical (OR 5.22; 95% CI 2.03–13.44; P = 0.0006) and clinical success (OR 4.16; 95% CI 2.00–8.66; P = 0.0001). EUS‐GBD was also associated with significantly lower rates of recurrent AC (OR 0.33; 95% CI 0.14–0.79; P = 0.01), while overall AEs were similar between the two groups (OR 1.30; 95% CI 0.77–2.22; P = 0.33). Expectedly, the rate of postprocedural acute pancreatitis was also significantly lower for the EUS‐GBD compared to ET‐GBD (OR 0.19; 95% CI 0.03–0.99; P = 0.05). When considering only the three studies where LAMS were utilized, the results were completely comparable to the overall analysis. Based on these findings, the meta‐analysis concluded that EUS‐GBD should be preferentially utilized over ET‐GBD for the endoscopic management of AC in high‐risk surgical patients. ³⁴

Related to the presented case, if a patient has an indication for ERCP for other reasons (such as biliary drainage, cholangitis, or choledocholithiasis), single‐session EUS‐GBD combined with ERCP should be considered, as it does not increase the risk of AEs as compared with EUS‐GBD alone, as recently reported. ³⁵

Case No. 4. Case with morbid obesity and a history of multiple abdominal surgeries

A 45‐year‐old morbidly obese (body mass index 45 kg/m²) man with previous abdominal surgeries presented with a clinical picture of AC. Abdominal ultrasound showed a gallbladder wall thickening up to 5 mm, with an impacted stone in the gallbladder infundibulum. Based on the nomograms by Goonawardena et al., ³⁶ this patient had an 80% probability of conversion to open cholecystectomy. EUS‐GBD with EC‐LAMS can be considered as a possible treatment option, which was offered to the patient after a thorough discussion.

In this setting, there are no data directly comparing LC vs. EUS‐GBD. However, in a retrospective propensity score study, ³⁷ 60 AC patients who had undergone either EUS‐GBD (30 patients) or LC (30 patients) were matched for age, sex, and age‐adjusted Charlson score. Technical and clinical success rates, lengths of hospital stay, 30 day AE, and mortality rates were similar between the two groups, as were rates of recurrent biliary events, reinterventions, and unplanned readmissions in the timeframe of 1 year. ³⁷ This study proved that in an expert setting, outcomes of EUS‐GBD performed in patients unfit for surgery were comparable with the laparoscopic approach. Patients with a high probability of conversion from laparoscopic to open cholecystectomy should also be potentially offered the alternative of EUS‐GBD, especially when elderly and frail, given the higher AE rate of the open surgical procedure. ³⁸ Prospective randomized studies comparing EUS‐GBD and LC in particular settings are necessary to better evaluate the findings of the above‐mentioned study. ³⁹

When EUS‐GBD is utilized in patients similar to the one described, in cases of stones larger than 15 mm that cannot pass spontaneously, intracholecystic lithotripsy should be performed (Fig. 2) until complete clearance is obtained following the Hong Kong protocol. The protocol consists of performing peroral cholecystoscopy at 4 weeks after EUS‐GBD, repeating it until complete stone clearance is reached. Replacement of the LAMS with a 7F DPPS is then performed, ⁸ a strategy suggested also by the recent Therapeutic EUS ESGE Technical guideline. ²⁰

Figure 2.

(a) Endoscopic ultrasound‐guided intracholecystic holmium laser lithotripsy performed through the previously positioned lumen‐apposing metal stent. (b) View at the end of the procedure showing the gallstones fragmented into small pieces.

Conversely, studies directly comparing PT‐GBD with LC reported that the percutaneous route is associated with a longer hospital stay, as well as higher readmission rates and mortality when compared to LC. ⁴ In a retrospective propensity score analysis, PT‐GBD had significantly higher rates of major AEs (65% vs. 12%, P < 0.001), recurrent biliary disease and interventions (53% and 66% vs. 5% and 12%, respectively, P < 0.001), as well as longer hospital stay (9 vs. 5 days, P < 0.001) than the control group. ⁴⁰ Despite these data, this suggest a potential major role of EUS‐GBD in this setting, the retrospective nature of the study cannot exclude potential enrollment bias towards an inclusion of sicker patients in the PT‐GBD arm.

Case No. 5. Elderly patient with dementia and preexisting heart failure

An 84‐year‐old man previously diagnosed with dementia presented with sepsis that worsened a preexisting long‐standing heart failure. His systolic blood pressure was 75/40 mmHg, with an oxygen saturation of 84%. A diagnosis of AC as the cause of patient decompensation was made. Due to the existence of contraindications to deep sedation, PT‐GBD was performed, with resolution of the sepsis. Internalization of the percutaneous drainage was performed a few days after the initial drainage procedure, after closing the external drain 24 h before to allow full gallbladder distension.

Percutaneous cholecystostomy has 95% clinical and technical success rates and represents the treatment of choice in patients with AC similar to the one presented above because it does not require deep sedation. ⁴¹ , ⁴² Additional contraindications to performing EUS‐GBD are the presence of a gangrenous or perforated gallbladder with peritonitis, and the absence of adequate expertise for performing the procedure safely and successfully (Table 1). PT‐GBD, however, bears the inconvenience of carrying an external drain that has to be properly taken care of. ⁴³ The procedure also carries risks of bleeding, bile leakage, and pneumothorax. ³ In the long term, the presence of an external drain presents risks of drain obstruction and infection, as well as drain dislodgement, especially in a patient with dementia, as described above. In this case, conversion to internal drainage by EUS‐GBD can be advantageous and should be done when the gallbladder can still be distended (Fig. 3), immediately after sepsis resolution.

Figure 3.

Endoscopic ultrasound‐guided cholecystoduodenostomy for internalization of drainage in a case with a previously positioned percutaneous cholecystostomy drain in place (arrow).

There are only two small case series reporting external drainage internalization. In the first one, among the seven patients reported, two had LAMS misdeployment and required additional placement of a metal stent, thus reaching a 100% technical success rate. No AEs were reported. ⁵ In the second study, there were only six patients included, in whom DPPS were used, with a technical success rate of 100%, but with peritonitis from bile leak occurring in one of the patients. ⁴⁴ Overall, the evidence of performing internalization of the previous PT‐GBD by using EUS‐GBD is limited but can be employed in experienced centers for patients who remain indefinitely unfit for surgery. The Hong Kong protocol for gallbladder stone clearance and LAMS replacement with a DPPS should be applied in this circumstance as well.

Case No. 6. Patient with peritoneal carcinomatosis and ascites

A 70‐year‐old man with peritoneal carcinomatosis from pancreatic tail cancer presented with AC poorly responsive to intravenous broad‐spectrum antibiotics. At abdominal ultrasound, the gallbladder was distended and painful during pressure with the transducer, with a small quantity of ascites present. After discussion in the tumor board, EUS‐GBD drainage was considered the least invasive approach. After advancement of the cystotome tip of the EC‐LAMS into the gallbladder from the duodenum, the endosonographic view was lost for a few minutes and resulted in spilling of bile into the peritoneal cavity. A guidewire was inserted and proven to be inside the gallbladder. The procedure was then performed under fluoroscopy with correct stent positioning. After the procedure, the patient developed diffuse peritonitis, for which surgical drainage was taken into consideration but eventually not performed because the patient ultimately responded to broad‐spectrum antibiotics.

The most common intraprocedural AEs are related to either difficult stent insertion or uncontrolled stent release (Fig. 4). Of utmost importance is timely recognition of these procedural events, so that adequate endoscopic salvage measures can be undertaken. Importantly, in the case of stent maldeployment, establishing or maintaining guidewire access is key for a successful rescue procedure, which can be accomplished by the insertion of an additional SEMS in order to successfully achieve sealing of the fistulous tract and gallbladder drainage. After stent maldeployment, however, there is an increased risk of perforation, bile leak, and peritonitis, which may require emergency surgery. Intraprocedural bleeding from vessels intercepted in the fistulous tract is generally quenched by LAMS expansion. On the other hand, extraluminal bleeding from lesions of the cystic artery, even if extremely rare, will most often require vessel embolization by interventional radiology.

Figure 4.

(a) Endoscopic ultrasound‐guided drainage of a small size gallbladder. (b) Electrocautery device was slowly advanced while applying pure cut current until its penetration into the gallbladder (arrow), followed by (c,d) distal and proximal lumen‐apposing metal stent flanges deployment. (e) Endoscopic control at the end of the procedure depicts a small perforation of the contralateral gallbladder wall harboring a circular cautery mark (arrow), which was (f) successfully closed with an endoscopic metal clip.

In a recent meta‐analysis aiming to identify all EUS‐GBD studies performed in the literature, ⁴⁵ the following AE rates related to the procedure were reported: bleeding in 4.3% (95% CI 2.7–6.8); perforation in 3.7% (95% CI 2.3–6.0); bile leak/bile peritonitis in 2.9% (95% CI 1.6–5.1); acute pancreatitis in 1.4% (95% CI 0.7–3.1); stent occlusion in 2.6% (95% CI 1.2–5.6); and stent migration in 2.7% (95% CI 1.3–5.4).

It appears that the overall frequency of nonfatal AEs is different by the type of stent utilized: 9.9% for EC‐LAMS; 12.3% for SEMS; and 18.2% for DPPS, as resulted from an earlier meta‐analysis. ¹⁹ To date, there is no report of any procedure‐related mortality. ¹⁹

SUMMARY

Endoscopic ultrasound‐guided gallbladder drainage for the treatment of patients with AC at high surgical risk is now considered a valid alternative to PT‐GBD in centers with expertise. Given its proven superiority over alternative gallbladder drainage methods, ESGE guidelines promoted EUS‐GBD to become the standard‐of‐care. ²³ However, much more work and education/training are still required to assure the adoption of EUS‐GBD in centers other than tertiary care ones, as well as the timely performance of the procedure if a proper indication exists. The best strategy for gallbladder drainage candidates should always be discussed and decided in multidisciplinary meetings, with a thorough review of clinical history, comorbidities, and risk of anesthesia and surgical interventions. Open questions that still need answers include identification of subsets of patients with AC in whom EUS‐GBD could provide benefits over the standard surgical approach, as well as more data on the role of EUS‐GBD as a bridge to surgery.

CONFLICT OF INTEREST

Author A.L. is a consultant for Boston Scientific and Pentax Medical. He has received research grant from Medtronic and lecture fees from Pentax Medical, Boston Scientific, Taewoong, M.I.Tech and Medtronic. The other authors declare no conflict of interest for this article.

FUNDING INFORMATION

None.