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. 2026 Jan 26;26:112. doi: 10.1186/s12893-026-03487-x

Summary of clinical evidence for biliary infection prevention strategies after percutaneous transhepatic biliary drainage: an evidence synthesis

Xiaoman Tao 1, Xiaomei Wang 1,✉, Huan Yu 1, Liyun Gong 1, Jiawei Zhang 1
PMCID: PMC12879407  PMID: 41582173

Abstract

Objective

To retrieve and extract the available evidence for the prevention of biliary tract infections associated with percutaneous transhepatic biliary drainage (PTBD) and provide evidence-based support for reducing their incidence.

Methods

Using the PIPOST tool, we formulated an evidence-based question and conducted searches in relevant Chinese and international databases and websites for clinical decisions, guidelines, evidence summaries, systematic reviews, randomized controlled trials and expert consensus on the use of management strategies for preventing post-PTBD biliary infections. The search was limited to the literature published until July 31, 2025. We performed a quality assessment and evidence extraction on the eligible documents.

Results

This study included 14 articles, including 6 guidelines, 3 expert consensus statements, 3 systematic reviews, and 2 randomized controlled trials. A total of 18 best pieces of evidence recommendations were summarized across 3 aspects, including preoperative preparation protocols for PTBD, intraoperative risk mitigation strategies, and postoperative care pathways for biliary infection prophylaxis.

Conclusion

This study systematically synthesized the evidence for preventing biliary tract infections following PTBD, thereby providing evidence-based support for the development of targeted clinical implementation strategies in practice.

Supplementary Information

The online version contains supplementary material available at 10.1186/s12893-026-03487-x.

Keywords: Percutaneous transhepatic biliary drainage, Biliary tract infections, Prevention, Evidence summary

Introduction

Percutaneous transhepatic biliary drainage (PTBD) is a minimally invasive interventional technique that involves placing a catheter into the intrahepatic bile ducts via an ultrasound-guided, percutaneous transhepatic approach [1]. The term “percutaneous transhepatic cholangiography drainage” (PTCD), which is synonymous with PTBD, is also used in the literature [2]. It is used to treat biliary obstruction and the consequent failure of bile drainage into the intestinal tract. This procedure aims to decompress the biliary system proximal to the obstruction level, which reduces intraductal hypertension, decreases serum bilirubin concentrations, and alleviates inflammatory responses within the biliary tree. This interventional approach offers two clinical benefits. First, PTBD establishes essential procedural access for subsequent interventions, including calculus retrieval, image-guided tumor ablation [3], and biliary stent placement. Furthermore, it effectively manages symptoms for patients with malignant obstructions who are ineligible for curative resection, thereby improving quality of life and prolonging survival [4]. Postprocedural biliary infection remains a predominant complication of PTBD, with reported incidence rates ranging from 14% to 47% [5]. In severe cases, the condition can progress to systemic inflammatory response syndrome (SIRS), which can then lead to multiple organ dysfunction syndrome (MODS) involving the hepatic, renal, and pulmonary systems. This progression significantly increases mortality risk [6]. The main causes of postoperative biliary tract infections include drainage methods, instrument contamination, biliary sludge, poor drainage, and the patient’s own immune status [7, 8]. Currently, systematic evaluations and randomized controlled trials on risk factors, assessments, and interventions for biliary tract infections after PTBD have been published nationally and internationally [5, 9–11]. To enhance procedural standardization and complication mitigation in ultrasound-guided PTBD, the Interventional Diagnostic Group of the Ultrasound Medicine Branch of the Chinese Medical Association released the 2023 Expert Consensus on PTBD [1]. This document establishes evidence-based protocols for puncture trajectory selection, postprocedural drainage efficacy evaluation, catheter stabilization, and complication management, thereby establishing initial clinical practice standards. However, critical limitations persist regarding infection prophylaxis, including fragmented evidence dispersion, an absence of comprehensive implementation frameworks, and insufficient high-level evidence syntheses specific to this patient population. Therefore, the present investigation was conducted to methodologically synthesize validated evidence on biliary infection prophylaxis following PTBD, establishing evidence-based clinical protocols to optimize perioperative management, mitigate procedure-related infection risks, and enhance patient-centered outcomes through standardized care pathways.

Materials and methods

Currently, reporting specifications for evidence summaries are lacking. The Fudan University Center for Evidence-Based Nursing has produced a reporting standard based on JBI methods for generating an evidence summary (see File S1). This standard includes problem formulation, literature retrieval, screening, evaluation, summarization, grading of evidence, and formulation of practical suggestions. The evidence summary utilizes the evidence summary reporting standard of the Fudan University Center for Evidence-Based Nursing (see File S2).

Problem establishment

The Fudan University Center for Evidence-based Nursing proposed the PIPOST model to solve the first step in the standard of evidence summary reports, that is, problem establishment [12]. In contradistinction to the conventional PICO model, it establishes a comprehensive framework centred on evidence utilisation, with explicit focus on defining target populations, intervention measures, evidence practitioners, application settings, outcomes, and evidence types. This study consisted of the following components. The first P (population) denoted patients who underwent percutaneous transhepatic biliary drainage (PTBD) for therapeutic indications. I (intervention) comprised multidimensional perioperative management strategies encompassing preprocedural preparation, intraoperative optimization, and postoperative care protocols. P (professional) consisted of evidence implementation targeted at interventional radiologists, hepatobiliary surgeons, and specialized nursing teams. O (outcome) included the primary endpoint of the incidence of post-PTBD biliary infections. The diagnostic criteria for biliary tract infection were as follows: (1) worsening jaundice symptoms; (2) an elevated white blood cell count (≥ 10 × 109/L); and (3) the presence of abdominal pain and fever. Pursuant to the fulfillment of the aforementioned criteria, in the absence of any indication of concurrent infectious diseases, a diagnosis of biliary tract infection can be made [13]. S (setting) referred to wards and operating rooms. T (type of evidence) encompassed clinical guidelines, expert consensuses, best practices, clinical decision-making, evidence summaries and systematic reviews. This study was registered with the Center for Evidence-Based Nursing, Fudan University, under registration number ES20257023.

Evidence retrieval

In accordance with the ‘6S’ pyramid model of evidence-based medicine [14], searches were conducted as follows: (1) Clinical Decision Support Systems: UpToDate, BMJ best practices; (2) Guideline Websites and Professional Association Websites: The National Guideline Clearinghouse (NGC), Registered Nurses' Association of Ontario (RNAO), the Scottish Intercollegiate Guidelines Network (SIGN), the World Health Organization (WHO), Guidelines International Network (GIN), the National Institute for Health and Clinical Excellence (NICE) in the UK, New Zealand Guidelines Group (NZGG), the Agency for Health care Research and Quality (AHRQ), and MediLink Guidelines; (3) Databases: Joanna Briggs Institute (JBI) Evidence-Based Health Care Center database, Cochrane Library, Clinical Trials, CINAHL, EBSCO, PubMed, Web of Science, China Knowledge Network Infrastructure (CNKI), Wanfang database, VIP database, and China Biomedical Literature Database. References were traced in addition to the aforementioned databases. The search was conducted using the following subject words + free words: “drainage/ percutaneous transhepatic biliary drainage/the National Institute for Health and Clinical Excellence/PTBD/PTCD” “infections/infection of biliary tract/biliary tract infection/biliary infection*”. The search deadline ranged from database establishment to July 31, 2025. An example of an English database search using PubMed with the corresponding search strategy is shown in Fig. 1. The search strategy for the complete database is shown in File S3.

Fig. 1.

Fig. 1

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PubMed search strategy

Inclusion and exclusion criteria for the literature

The inclusion criteria were as follows: (1) studies involving patients undergoing PTBD for clinically indicated therapeutic interventions; (2) comprehensive perioperative management strategies encompassing preprocedural optimization, intraoperative technical standardization, and postprocedural care protocols; (3) type of evidence consisting of best clinical practice, clinical guidelines, expert consensus, expert opinion, systematic evaluation, and randomized controlled studies; and (4) literature in English and Chinese. The exclusion criteria were as follows: (1) inability to obtain full-text literature, literature with duplicate publications or incomplete information; (2) interpretations or translated versions of foreign guidelines and nonlatest or abbreviated versions of guidelines; (3) studies judged to be of low quality according to the literature quality assessment criteria.

Literature screening

The retrieved literature was imported into EndNote, and duplicates were eliminated. Two researchers who were trained in evidence-based medicine independently screened the literature. During the initial screening, they reviewed the titles, abstracts and keywords. They subsequently read and rescreened the full texts, evaluating the quality of the rescreened literature. If there was controversy over the inclusion of a retrieved document during the assessment, it was discussed with a third expert in evidence-based nursing to determine its inclusion status.

Quality evaluation of the literature

  1. Quality Evaluation Criteria for Clinical Guidelines: The quality of the included guidelines was evaluated according to the Appraisal of Guidelines for Research and Evaluation II (AGREE II) [15]. Two researchers who had undergone systematic learning of evidence-based methodology independently conducted the quality evaluation of the guidelines. Conduct consistency testing on the evaluation results utilized intragroup correlation coefficients. The evaluation criteria consisted of six fields, 23 items, and two guidelines for the overall evaluation. Each item was rated on a scale from 1 to 7 points, with 1 point indicating complete noncompliance and 7 points indicating complete compliance. The sum of the scores for all the items in each domain was calculated and then standardized as a percentage of the maximum possible score for that domain. These standardized scores were used to determine the quality of the guidelines. This study excluded Level C literature. The recommendation of the guide was divided into three levels: A level (strong recommendation), with scores of ≥ 60% in all six areas of the guide; B level (recommended), referring to areas with a score of < 60% and ≥ 3areas with a score ≥ 30% ; and C level (not recommended), with a score of < 30% in ≥ 3 fields.

  2. Quality Evaluation Criteria for Systematic Reviews: Two researchers conducted independent evaluations using the 2016 edition of the JBI Centre for Evidence-Based Health Care’s systematic review criteria [16], which consisted of eleven items and resulted in “yes,” “no,” “unclear,” or “undetermined” evaluations.

  3. Quality Evaluation Criteria for Expert Consensus: Independent evaluations were conducted by two researchers using the JBI Expert Consensus Assessment Criteria (2016 version) [16], which comprises six items and is rated as “yes”, “no”, “unclear”, or “undetermined”.

  4. Quality Evaluation Criteria for Randomized Controlled Trials: The methodological quality of randomized controlled trials was evaluated using the Risk of Bias Assessment Tool 2.0 (ROB2). The Cochrane Collaboration published the ROB2 in 2019 [17]. Two researchers independently conducted the quality evaluation of the randomized controlled trials. ROB2 focuses on five core domains of bias, covering critical stages from trial design to results reporting. For each domain, preset response options (“yes,” “probably yes,” “probably no,” or “no”) were color coded to indicate varying levels of bias risk (green = low risk; red = high risk). On the basis of the responses across all the domains, the overall risk level was determined as follows: “low risk,” “high risk,” or “some concerns”.

Evaluations were conducted by researchers who had received evidence-based training and held a graduate degree in nursing. In cases of conflicting opinions, resolution was achieved through negotiation or the involvement of a third researcher. When evidence from different sources was repeated or conflicting, the following should be prioritized when evidence is selected: evidence-based, high-quality, and the latest [18].

Evidence extraction, integration, and summarization

Two researchers independently extracted evidence, focusing on key aspects of the prevention of biliary tract infections. The extracted information included the publication date, study type, source of evidence, evidence topic, and specific content. All the researchers participated in the process of translating, extracting, and integrating the evidence. Principles of evidence integration were as follows. (1) If the evidence is consistent, prioritize concise, clear, and professional content. (2) When the content of the evidence complements each other, it is merged into logically structured statements. (3) If there are differences in the content of the evidence, the evidence is prioritized on the basis of the following principles: evidence-based, high-quality, authoritative, and recently published. In this study, four researchers were divided into two groups to evaluate the original literature included in the evidence on the basis of the JBI Evidence Pre-Grading and Recommendation Grading System [18]. In cases of disagreement, all four members discussed the topic and made a decision. The evidence was categorized from “highest level” to “lowest level” on the basis of the type of original research and further classified into levels 1a to 5c. Recommendation levels were divided into A-level recommendations (strong recommendation) and B-level recommendations (weak recommendation) on the basis of feasibility, suitability, clinical significance and effectiveness [18].

Results

General characteristics of the included studies

This study included a total of 14 articles, comprising 6 guidelines, 3 expert consensus papers, 3 systematic reviews, and 2 randomized controlled trials. The literature selection process is illustrated in Fig. 2, and the general characteristics of the included literature are presented in Table 1.

Fig. 2.

Fig. 2

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Literature screening workflow

Table 1.

General characteristics of the included studies (n=14)

Author Publication
Year		 Source Type Topic
WSES [19] 2017 PubMed Guidelines Management of intraabdominal infections in the global view
Gomi et al[20] 2018 PubMed Guidelines Antimicrobial treatment of acute cholangitis and cholecystitis
SIR[21] 2020 PubMed Guidelines Quality improvement criteria for percutaneous cholecystostomy and percutaneous transhepatobiliary intervention
CIRSE[22] 2021 PubMed Guidelines Standard of practice for percutaneous transhepatobiliary angiography, biliary drainage and stenting
Society of Surgery of Chinese Medical Association[23] 2021 CNKI Guidelines Diagnosis and treatment of an acute biliary system infection
SIS[24] 2024 PubMed Guidelines Management measures related to intra-abdominal infection
Jin L et al[25] 2019 CNKI Expert Consensuses Percutaneous liver puncture for biliary drainage and stent implantation for obstructive jaundice
CACA et al[7] 2020 CNKI Expert Consensuses Tubular care for percutaneous liver puncture and biliary drainage
Ultrasonic Committee of Chinese Medical Association[1] 2023 CNKI Expert Consensuses Standardization of ultrasound-guided percutaneous transhepatic cholangioperitoneal perforation for drainage
Wang FY et al[26] 2022 VIP Database Systematic review Risk factors for biliary tract infections after percutaneous hepatic puncture biliary drainage in patients with malignant obstructive jaundice
Li YL et al[27] 2023 CNKI Systematic review The effect of extended care on complications in patients discharged from hospital after percutaneous transhepatic perforation biliary drainage
Y. L. Huang et al[11] 2024 PubMed Systematic review Efficacy and safety analysis of continued nursing of complications in discharged patients after percutaneous transhepatic biliary drainage
Behera et al[28] 2021 Cochrane Library Randomised controlled studies Efficacy and safety of right versus left percutaneous hepatic perforation biliary drainage in patients with malignant biliary obstruction
Peng et al[29] 2023 Cochrane Library Randomised controlled studies Efficacy and complications of different methods of drain fixation for percutaneous biliary drainage
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Abbreviations: WSES World Society of Emergency Surgery, SIR Society of Interventional Radiology, CIRSE Cardiovascular and Interventional Radiological Society of Europe, SIS Surgical Infection Society, CACA China Anti-Cancer Association, CNKI (China National Knowledge Infrastructure) is the most authoritative and comprehensive literature database in China, with the largest collection of journals and number of documents

Quality assessment results of the included literature

Quality assessment results of guidelines

This study included a total of 6 guidelines [19–24]. The standardized percentage scores for each domain and the overall assessment opinions are presented in Table 2.

Table 2.

Methodological quality assessment of the included guidelines

Guidelines Standardized Score in Each AGREE II Domain(%) >60%
Number of fields
(number)		 <30%
Number of fields
(number)		 ICC Recommended
Level
(Grade)
Scope and
Purpose		 Stakeholder(s) Rigor of
Development		 Clarity of
Presentation		 Applicability Editorial
Independence
WSES[19] 91.67 91.67 76.04 88.89 68.75 75.00 6 0 0.92 A
Gomi et al[20] 61.11 91.67 94.79 66.67 50.00 70.83 5 0 0.90 B
SIR[21] 83.33 91.67 79.17 72.22 70.83 100.00 6 0 0.93 A
CIRSE[22] 41.67 72.22 37.50 50.00 43.75 87.50 2 0 0.91 B
Society of Surgery of Chinese Medical Association[23] 77.78 42.22 52.08 77.78 60.42 83.33 4 0 0.88 B
SIS[24] 100.00 69.44 64.58 88.87 64.58 62.50 6 0 0.91 A
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Abbreviations: WSES World Society of Emergency Surgery, SIR Society of Interventional Radiology, CIRSE Cardiovascular and Interventional Radiological Society of Europe, SIS Surgical Infection Society, ICC Intraclass Correlation Coefficient

Quality assessment results of expert consensus

This study included a total of 3 expert consensuses. One had “yes” for all the entries [25], two others had “no” for entry 6, and the rest had “yes” for the remaining entries [1, 7]. These were included in the analysis. The quality assessment results are presented in Table 3.

Table 3.

Quality evaluation of expert consensuses (n=3)

Items Jin L et al[25] CACA et al[7] Ultrasonic Committee of Chinese Medical Association[1]
1.Clarity of the source of opinions? Yes Yes Yes
2.Opinions derived from influential experts? Yes Yes Yes
3.Focus on the welfare of the study population? Yes Yes Yes
4.Conclusions based on results and presented with logical expression? Yes Yes Yes
5.Reference to other existing literature? Yes Yes Yes
6.Consistency with other opinions? Yes No No
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Abbreviations: CACA China Anti-Cancer Association

Quality assessment results of systematic reviews

This study included 3 systematic reviews [11, 26, 27]. The quality assessment results are presented in Table 4.

Table 4.

Quality evaluation results of systematic reviews (n = 3)

Items Wang FY et al[26] Li YL et al[27] Huang, YL et al[11]
1. Is the review question clearly and explicitly stated? Yes Yes Yes
2. Were the inclusion criteria appropriate for the new question? Yes Yes Yes
3. Was the search strategy appropriate? Yes Yes Yes
4. Were the sources and the resources used to search for studies adequate? Yes Yes Yes
5. Were the criteria for appraising studies appropriate? Yes Yes Yes
6. Was critical appraisal conducted by two or more reviewers independently? Yes Yes Yes
7. Were there any measures in place to minimize errors in the extraction of literature? Yes Yes Yes
8. Were the methods used to combine studies appropriate? Yes Yes Yes
9. Was the likelihood of publication bias assessed? Yes Yes Yes
10. Were recommendations for policy and/or practice supported by the reported data? Yes Yes Yes
11. Were the specific directives for new research appropriate? Yes Yes Yes
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Quality assessment results of randomized controlled trials

Two randomized controlled studies were included [28, 29]. The quality assessment results are presented in Fig. 3.

Fig. 3.

Fig. 3

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Quality evaluation of randomized controlled trials [28, 29]

Summary of evidence

In this study, we summarized 21 items of best evidence from 3 aspects, including preoperative preparation protocols for PTBD, intraoperative risk mitigation strategies, and postoperative care pathways for biliary infection prophylaxis. Please refer to Table 5 for details.

Table 5.

Summary of the best evidence for biliary infection prevention strategies after PTBD

Category Evidence Content Evidence Level Recommendation
Level

Preoperative Stage

Intraoperative Stage

Postoperative Stage

 1. Conduct comprehensive laboratory and imaging studies, including complete blood count, coagulation profile, liver and kidney function tests, assessment off infection-related markers, electrocardiogram, ultrasound, and CT/MRI, among others. [1, 22, 25]. 5b A
2. Risk factors for biliary infection: (1) patients with bilioenteric anastomosis; (2) previous biliary instrumentation; (3) advanced age (> 70 years old); (4) obstructive jaundice; (5) acute cholecystitis; (6) diabetes mellitus; (7) previous PTBD [22, 30]. 3b A
3. Operators must undergo professional medical imaging training and assessment, ensuring strict adherence to aseptic technique principles [1, 22]. 5b B
4. Recommend administering intravenous (IV) single-dose antibiotic formulations within one hour after the incision. [21, 22, 24, 25, 30]. 5b B
5. Recommend to collect bile for bacterial culture at the onset of any invasive diagnostic or therapeutic procedure, preferably before the initiation of antimicrobial therapy [19, 21, 22]. 5b A
6. Method of anesthesia: Ultrasound-guided local anesthesia with 1%-2% lidocaine combined with sedatives (midazolam 2–6 mg, fentanyl 25–100 µg) is recommended, with anesthesia depth reaching the hepatic capsule [1, 19]. 5b A
7. Conducting method: Recommend ultrasound-guided puncture [20, 22]. 5b B
8. Selection of puncture site: When conditions permit, left-sided puncture should be prioritized[22]. 1c A
9. Recommend single-wall bile duct piercing[25]. 5c B
10. Strategies for drainage: (1) Indications for External Drainage: (a) A poor general condition of the patient makes it difficult to tolerate prolonged procedures. (b) There is clear biliary tract infection, requiring unobstructed drainage to be achieved with minimal intervention. (c) The patient is scheduled to undergo surgical tumor resection in the near future. The primary purpose of catheter placement is to alleviate jaundice and restore liver function. (d) The guidewire cannot pass through the obstructed segment to reach the distal bile duct or intestine beyond the obstruction. (e) Multiple intrahepatic bile duct obstructions require drainage of two bile ducts using a single drainage tube. (2) Indications for Internal and External Drainage: (a) Patients with external drainage will be converted to internal drainage later once their condition stabilizes. (b) This approach can serve as a transitional measure during the initial phase of internal drainage. [7, 25] 5b A
11. Evaluate nutritional status and, for patients at nutritional risk or with malnutrition, collaborate with nutrition professionals to conduct further comprehensive nutritional assessments and develop nutritional treatment plans [7, 31]. 4b A
12. A modified method of securing the drain tube is recommended (the drain tube is inserted into the ostomy bag, and after the tube has been wrapped and secured, the ostomy bag is secured to the patient and then attached to the drainage bag)[29]. 1c A
13. Postoperative catheter care should be performed by a certified interventional radiologist or a nurse practitioner who has successfully completed a certified competency assessment program[7]. 5b B
14. Maintain unobstructed drainage pathways and clear labeling. Monitor and evaluate the color, consistency, and volume of the drainage fluid [1, 7]. 5b A
15. Regular catheter maintenance should be performed. For specific catheter maintenance procedures, refer to File 4 [7, 32]. 5b A
16. Oral administration of drained bile is recommended to help improve the patient’s gastrointestinal function and nutritional status, reduce the loss of water and electrolytes, and promote the recovery of liver function [33, 34]. 1c B
17. Scheduled biochemical monitoring (including hepatic panels and hematologic profiles) at weekly to monthly intervals is recommended, concomitant with elective replacement of catheter systems at 3–6 month cycles[7, 22, 35]. 5b A
18. It is recommended that hospitals implement continuity of care measures for patients after PTBD until drain removal [11, 27]. 2a A
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Discussion

Preoperative assessment stage

The study concluded that the risk of PTBD is relatively low. However, postoperative bleeding, infection, and catheter dislodgement may be associated with serious complications or even death. Therefore, a thorough preoperative assessment of patients is essential [1]. Notably, uncorrectable coagulation disorders represent the only absolute contraindication [22, 25]. Biliary obstruction frequently causes impaired absorption of fat-soluble vitamin K, affecting the synthesis of coagulation factors (II, VII, IX, X) and subsequently leading to a prolonged prothrombin time. Therefore, for patients with significant bleeding tendencies, immediate correction should be performed preoperatively to reduce the risk of intraoperative and postoperative bleeding. The currently accepted preoperative safety thresholds are an international normalized ratio (INR) < 1.5 and a platelet count > 50,000/µL [22]. Common imaging modalities include ultrasound, CT, and MRI. Ultrasound aids in determining the nature of lesions and differentiating between obstructive jaundice and hepatocellular jaundice. CT/MRI assists in planning optimal puncture pathways to achieve targeted bile duct drainage with minimal trauma, reducing damage to the liver parenchyma and blood vessels. This approach decreases the risk of hematogenous infection and bile leakage [25]. Not all patients face an equal risk of developing postoperative biliary tract infections. High-quality evidence recommends identifying high-risk populations and implementing enhanced interventions as crucial steps toward achieving effective prevention [30]. A standardized puncture operation can significantly reduce the risk of vascular and bile duct injuries, thus reducing postoperative bleeding (40%-60% reduction in incidence) and infection rates (approximately 35% reduction) [23]. On the one hand, operators must satisfy the following competency criteria: (1) hold valid medical imaging licensures with specialized hepatobiliary ultrasonography certification; (2) successfully complete standardized interventional radiology training demonstrating proficiency in independent performance of Level I-II ultrasound-guided procedures; and (3) perform ≥ 20 supervised ultrasound-guided PTBD procedures under attending physician supervision [1]. This information suggests that medical units at all levels should increase the standardized training of operators, the stage qualification system and the support of clinical practice resources. Nevertheless, variations in health care settings, constraints on working hours, and heavy workloads may impact the standardization of physician training and procedural proficiency. To meet clinical demands, virtual simulation demonstrations could replace conventional training methods in the future [36]; concurrently, advanced-level physicians should provide guidance during catheterization procedures to optimize success rates and improve patient comfort. On the other hand, maintaining a strict aseptic technique constitutes the fundamental principle for invasive interventions. Operators must adhere to full sterile precautions, including surgical gowns, double-gloving, and respiratory protection, with mandatory utilization of sterile probe covers and ultrasound coupling gel to prevent transducer-mediated contamination—a critical consideration in PTBD [1].

Intraoperative procedure stage

Biliary stasis caused by biliary obstruction provides a favorable environment for microbial proliferation, resulting in purulent secretions or bacterial colonization in approximately 70% of obstructed systems [37]. Therefore, PTBD performed on such patients should be considered a procedure with a high risk of contamination [38]. The risk of bacteremia associated with this procedure warrants significant attention. Data indicate that 7.7% of catheterization procedures result in mild sepsis, with an additional 2.5% of cases potentially progressing to life-threatening severe sepsis [39]. In this context, the prophylactic use of antibiotics becomes particularly crucial. Defined as antibiotics administered prior to surgical incisions or punctures, the primary purpose of antibiotics is to promptly eliminate bacteria introduced into the bloodstream during the procedure, thereby effectively preventing the onset of a systemic inflammatory response. A prospective, randomized, double-blind study by Stone et al. (enrolling 400 patients undergoing elective gastric, biliary, and colorectal surgery) demonstrated that preoperative antibiotic administration significantly reduced the incidence of surgical site infections. In contrast, patients who received antibiotics only after surgery had infection rates comparable to those in the nonantibiotic group (15% vs. 16%) [40]. Based on this evidence, current consensus recommendations from hospital and patient safety organizations advise administering a single intravenous dose of antibiotics within one hour of surgical incision [30]. Walter et al. further supported this 60-minute administration window through a large-scale phase 3 randomized controlled trial and reported no additional benefit from narrowing this window [41]. Commonly used prophylactic antibiotic regimens in clinical practice include (1) 1 g intravenous injection of ceftriaxone; (2) 1.5–3 g intravenous injection of ampicillin/sulbactam; (3) 1 g intravenous injection of cefotetan combined with 4 g intravenous injection of meropenem; and (4) 2 g intravenous injection of ampicillin combined with gentamicin (1.5 mg/kg). However, a recent retrospective study reached a different conclusion regarding the efficacy of prophylactic antibiotics. Lei et al. compared postoperative biliary tract infection rates between 25 patients who received antibiotics 0.5 to 2.0 h before surgery and 300 patients who did not during the period from June 2016 to June 2020. The infection rates were 8.0% and 20.7%, respectively, which were not significantly different (χ²=2.34; P = 0.13) [5].Similarly, Turan et al. [42]conducted a study on 331 patients undergoing PTBD at one academic hospital and four teaching hospitals. Their findings indicated that prophylactic antibiotic use did not result in a substantial reduction in postoperative infection complications within this patient population. The potential causes of these discrepancies are manifold: Firstly, patient cohorts across studies exhibited heterogeneity, including variations in underlying biliary pathology, obstruction severity, and immune function. Secondly, inherent selection bias and confounding factors in retrospective study designs may compromise the comparability of results. Furthermore, the definitions of infection, the durations of follow-up, and the assessment criteria exhibited significant variability across the studies. This finding indicates that the clinical benefit of prophylactic antibiotics may be influenced by multiple factors, including surgical type, patient baseline conditions, local microbiological epidemiology, and differences in antibiotic prophylaxis strategies among healthcare institutions.It is recommended that future research concentrate on the following dimensions: The potential impact of local resistance patterns across different healthcare institutions and regions on the efficacy of empirical prophylaxis regimens must be systematically evaluated. Furthermore, risk stratification models based on patient clinical characteristics (e.g. the etiology of biliary obstruction, the severity of jaundice and immune function status) should be established in order to precisely identify high-risk subgroups likely to derive actual benefit from antibiotic prophylaxis. This more nuanced, context-specific analytical framework will further advance clinical practice in this field towards individualised and precision-based approaches.

Importantly, single-dose prophylaxis is sufficient in most cases. A prolonged duration of antibiotic treatment does not further reduce infection risk, but it may increase adverse reactions and induce bacterial resistance. Therefore, routine collection of bile samples for bacterial culture is strongly recommended during procedures [21]. This strategy facilitates the transition from “empirical antimicrobial therapy” to “targeted antimicrobial therapy.” It provides clinicians with precise antibiotic selection criteria when signs of infection emerge postoperatively, thereby improving patient outcomes and helping curb the development of bacterial resistance. Collection should typically occur prior to antimicrobial treatment initiation. Even a single dose of antibiotics may inhibit bacterial growth, leading to false-negative culture results and potentially compromising the optimal opportunity to obtain precise antimicrobial susceptibility information. As an invasive procedure, PTBD necessitates meticulous pain management and sedation to ensure patient tolerance and procedural safety. Current protocols recommend ultrasound-guided 1–2% lidocaine infiltration with subcapsular hepatic localization combined with midazolam (2–6 mg) for benzodiazepine sedation and fentanyl (25–100 µg) for opioid analgesia. This approach achieves the dual benefits of enhancing patient compliance while minimizing needle-passage discomfort, thereby decreasing complications associated with multiple puncture attempts, including hemorrhage and biliary leakage [1, 25]. DSA clearly displays the vascular anatomy and hemodynamics, and when combined with ultrasound, it provides complementary advantages, which is crucial for the successful performance of PTBD procedures on patients with complex diseases [22, 25]. During PTBD procedures, one of the key factors determining surgical success and safety is the selection of the puncture pathway. While the traditional right-sided approach is typically employed because of its relatively straightforward access, mounting evidence suggests that left-sided puncture leads to a lower incidence of postoperative complications (11.4% versus 24% for the right side, p < 0.001) [43]. Furthermore, a recent randomized trial by Castiglione et al. revealed that the left-sided approach resulted in higher quality-of-life scores, less intercostal pain and less dyspnea among patients [44]. Some scholars believe that single-arm puncture has a lower incidence of postoperative complications than transmural puncture does, but it requires precise image guidance and greater operator experience [25]. Notably, percutaneous transhepatic cholangiography remains a necessary option even when intrahepatic bile duct dilation is not prominent [45]. The drainage methods for PTBD primarily include external drainage and combined internal–external drainage. External drainage is simple, requires no intestinal anastomosis, and has a relatively low incidence of postoperative cholangitis [46]. In contrast, combined drainage offers bidirectional decompression by providing both external diversion and establishing an enteral pathway. This approach not only enhances catheter stability but also avoids the electrolyte imbalances potentially caused by long-term external drainage. In clinical practice, strict adherence to the indications for each drainage method is essential. A personalized drainage strategy should be developed on the basis of patient preferences and anticipated treatment goals to enhance surgical safety and minimize complication risks [1, 7, 25].

Postoperative management stage

Nutritional status is a fundamental yet often overlooked factor that plays a crucial role in regulating postoperative recovery and infection risk in patients. Statistics indicate that up to 50% of patients with obstructive jaundice are malnourished, and the incidence is even greater among those with malignant obstructive jaundice [7]. This phenomenon may be due to prolonged biliary obstruction causing impaired digestive absorption and triggering symptoms such as anorexia and nausea, which exacerbate nutritional imbalance. Therefore, standardized nutritional risk screening is recommended for all patients scheduled for PTBD. For those with abnormal results, multidisciplinary collaboration involving clinicians, dietitians, and nurses should be initiated. Dietitians can conduct comprehensive assessments through dietary surveys, body composition analysis, and energy expenditure measurements to develop personalized nutritional support plans. These plans should adhere to the ‘enteral nutrition first’ principle: for patients with preserved gastrointestinal function, early enteral feeding via a nasogastric or jejunal feeding tube should be initiated to reabsorb bile. Alternatively, oral feeding may be attempted after rigorous evaluation [34, 35]. This strategy helps maintain the integrity of the intestinal mucosal barrier, prevents bacterial translocation, and improves the nitrogen balance in a more physiologically consistent manner. It is important to note that, despite the theoretical benefits of oral bile as a non-invasive and convenient treatment, its efficacy remains unproven in large-scale studies. Implementation issues arising from low patient compliance further compound the challenges associated with its widespread adoption. This finding indicates that the restoration of bile drainage alone may be inadequate to fully reverse metabolic disorders. It is recommended that future research focus on the physiological effects of different reinfusion methods at the level of bile metabolism mechanisms.Despite the existence of clear guideline recommendations, the clinical implementation of multidisciplinary nutritional support still faces significant barriers. These include the inequitable allocation of dietitian resources across various hospital levels, apprehensions regarding enteral nutrition tolerance potentially postponing its initiation, and patient acceptance concerns relating to tube feeding. Consequently, future research should not merely demonstrate the efficacy of nutritional support, but must also explore how to establish practical, cost-effective, standardised nutritional intervention pathways in resource-limited settings. Additionally, maintaining the drainage tube and preventing complications are critical components of standardized postoperative PTBD management. This process primarily involves the following measures. First, interventional specialists or nurses should be trained and evaluated to ensure the high-quality implementation of primary care [7]. Second, the catheter placement and drainage status are observed. The labels on the catheters are checked to confirm the placement time, drainage method, insertion site, and length of the exposed catheter. Secure fixation of the drainage tubes and unobstructed flow of the drainage fluid should be ensured. The color, consistency, and volume of the drainage fluid should be monitored [1]. Ken et al. conducted a randomized controlled trial involving 68 patients who underwent percutaneous transhepatic biliary drainage (PTBD) [29]. The patients were randomly assigned to one of two groups: Group A (conventional fixation method) and Group B (modified fixation method), each of which comprised 34 patients. The results revealed no statistically significant difference in early complication rates between the two groups (Group B: 38.24% vs. Group A: 41.18%; P > 0.05). However, the incidence of late postoperative complications in Group B (6/34) was significantly lower than that in Group A (16/34) (P < 0.05). Therefore, the modified drainage tube fixation method has been recommended because it significantly improves patients’ quality of life and effectively reduces the incidence of late postoperative complications. Third, regular care of the catheter and puncture site is recommended [7, 33]. Daily flushing of the drainage tube with saline solution can effectively prevent blockage caused by thrombi or bile sludge, reduce the risk of pathogenic microorganisms colonizing the site, prevent cholestasis caused by catheter obstruction, and control postoperative biliary tract infections. Implementing standardized catheter care protocols, including staged dressing and drainage bag changes with strict sterilization, achieves the dual objectives of infection prevention and cost optimization (see File S4 for specific procedures). Fourth, it is recommended that patients undergo weekly or monthly follow-up examinations of liver function and complete blood counts after discharge to monitor the resolution of biliary obstruction and recovery of liver function dynamically [7, 22]. This management approach enables risks such as infection, bleeding, and liver damage to be identified early. For patients requiring long-term indwelling drainage tubes, the drainage tube should be replaced every 3 to 6 months to optimize quality of life and reduce nursing costs. Continuing care is vital for patients who are transitioning from hospital to home or community settings. Providing systematic posthospitalization health guidance and follow-up services ensures that the continuity of inpatient care is maintained. Its primary objectives are to minimize the risk of complications, reduce unplanned readmissions, and facilitate patients’ overall recovery. A recent systematic review further confirmed the pivotal role of percutaneous transhepatic biliary drainage (PTBD) in the management of patients. The study synthesized nine clinical trials involving 853 patients (429 in the intervention group and 424 in the control group) [11]. The results of the meta-analysis demonstrated that patients who received extended care, including telephone guidance, 25 microblogs, home visits, and hospital–community–home coordination, had significantly better outcomes across multiple key measures compared with those who received standard care. Specifically, the following were significantly reduced: (1) biliary tract infections (RR = 0.42, 95% CI: 0.30–0.57); (2) wound infection at the puncture site (RR = 0.19, 95% CI: 0.06–0.65); (3) catheter dislodgement or displacement (RR = 0.31, 95% CI: 0.18–0.54); (4) catheter obstruction (RR = 0.23, 95% CI: 0.13–0.42); and (5) percutaneous skin infection around the drainage tube (RR = 0.30, 95% CI: 0.12–0.77; catheter-related readmission (RR = 0.34, 95% CI: 0.18–0.65). Notably, the current continuity of care models are relatively limited in scope, with a focus primarily on objective indicators such as post-operative catheter care guidance for patients. However, multiple qualitative studies exploring the lived experiences of patients with PTBD catheters have revealed that, beyond common concerns about catheter dislodgement and infection, patients frequently experience psychosocial distress, including disruption to self-image, social avoidance, persistent physical discomfort, and negative emotions [47–49]. These psychological pressures directly impact patients’ quality of life and may exacerbate inflammation, delay tissue repair, and reduce treatment adherence by activating neuroendocrine and immune stress pathways, creating a vicious cycle of physiological and psychological deterioration and thus increasing the risk of complications like infection. Therefore, establishing a comprehensive follow-up care model that incorporates psychosocial support is crucial for improving patients’ long-term outcomes.

Finally, when biliary drainage strategies are formulated, in addition to PTBD, the following are effective minimally invasive alternatives: endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic nasobiliary drainage (ENBD) or stent placement and endoscopic ultrasound-guided biliary drainage (EUS-BD). Each of these methods has distinct characteristics [50–52]. ERCP with drainage as a primary treatment option has the advantage of following physiological pathways but is associated with an increased risk of postoperative pancreatitis and cholangitis. ENBD allows bile characteristics to be observed but poses risks of nasal discomfort and catheter dislodgement. EUS-BD is a critical alternative following ERCP failure. Creating a gastrointestinal-biliary drainage pathway eliminates the need for external catheters, which significantly improves patients’ quality of life and reduces the risk of infection at the puncture site and bacteremia that are commonly associated with PTBD. However, this technique has unique complications, such as stent displacement or peritonitis due to bile leakage. Consequently, PTBD remains irreplaceable in the following scenarios: (1) complex hilar obstructions or multiple intrahepatic bile ducts requiring separate drainage; (2) anatomical alterations from prior gastrointestinal surgery that preclude endoscopic intervention; and (3) the need to establish a stable access point for repeated biliary interventions. In summary, selecting the optimal drainage approach requires a thorough evaluation of the location and nature of the obstruction, the patient’s anatomy, the technical expertise available, and the infection risk profile of each technique.

Limitations

The summary of evidence in this study provides a theoretical basis for preventing postoperative biliary tract infections with PTBD, but there are also certain limitations. (1) This study included only Chinese and English literature, which may overlook high-quality research results in other languages. (2) Most of the collected literature were from China, and the study results may be affected by regional and cultural background; some intervention measures cannot provide standardized practical recommendations.(3)The evidence structure impacts the certainty of recommendations. This study primarily relied on guidelines, expert consensus statements, and systematic reviews, including only two randomized controlled trials (RCTs). Consequently, the recommendations are largely based on indirect evidence and expert opinion, lacking direct validation from primary clinical trials. This poses challenges in formulating unified, highly actionable recommendations, resulting in guidance that is more principle-based.

Conclusion

This study provides a systematic summary of the 18 key points for preventing postoperative biliary tract infections following PTBD. It covers three areas: preoperative assessment and risk control, intraoperative procedural standards, and postoperative catheter management and extended care. This study provides a structured reference for China’s healthcare system clinical practice. Despite the fact that extant evidence is primarily derived from domestic clinical settings, meticulous evaluation with consideration for patient variability and specific institutional conditions remains imperative during implementation. Nevertheless, the infection prevention pathways and localized experience highlighted herein hold reference value for middle-income countries and regions facing similar challenges.There are significant evidence gaps in this field, particularly regarding the standardized use of prophylactic antibiotics, for which there is a lack of support from high-quality randomized controlled trials. To effectively implement these evidence-based recommendations in China and optimize patient outcomes, a patient-centered, multidisciplinary collaboration model is recommended. Throughout the perioperative period, interventional radiologists, hepatobiliary surgeons, anesthetists and specialist nurses must work closely together: interventionalists perform precise procedures, surgeons determine overall indications, anesthetists regulate physiological states, and specialist nurses implement detailed management and health education. Current international guidelines explicitly emphasize that this integrated, multidisciplinary approach is crucial for minimizing complications and ensuring patient safety. It is recommended that future research efforts concentrate on conducting a greater number of high-quality local studies. This would serve to strengthen the evidence base and facilitate further exploration of multidisciplinary collaboration implementation pathways and optimisation strategies that are tailored to China’s healthcare resource allocation characteristics.

Supplementary Information

Supplementary Material 1. (703.6KB, docx)
Supplementary Material 2. (170.1KB, docx)
Supplementary Material 3. (15.6KB, docx)
Supplementary Material 4. (16.7KB, docx)

Acknowledgments

Disclosure

None of the authors has personal, financial, commercial, or academic conflicts of interest.

Authors’ contributions

Xm T（First author）contributed to the design of the work, the Literature acquisition, analysis and writing-original draft. Xm W (Corresponding author) supervised the writing of and revision of the manuscript. H Y and Xm T performed the literature searching.Jw Z, Ly G and Xm evaluated the quality of literature. All authors discussed the results and contributed to the final manuscript.

Funding

This study did not receive any funding in any form.

Data availability

All the data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.

Declarations

Ethics approval and consent to participate

An ethics statement is not applicable because this study is based exclusively on published literature.

Competing interests

The authors declare no competing interests.

Footnotes

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplementary Material 1. (703.6KB, docx)
Supplementary Material 2. (170.1KB, docx)
Supplementary Material 3. (15.6KB, docx)
Supplementary Material 4. (16.7KB, docx)

Data Availability Statement

All the data generated or analyzed during this study are included in this article. Further enquiries can be directed to the corresponding author.

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