Performance and safety of percutaneous cholangioscopy: a systematic review and meta-analysis.

Background: Percutaneous cholangioscopy (PerC) offers an alternative for patients with an inaccessible biliary tree. This systematic review and meta-analysis aimed to evaluate the performance of this technique. Methods: A search in Medline, Cochrane and ClinicalTrials.gov databases was performed for studies assessing PerC up to October 2022. The primary outcome was diagnostic success, defined as successful stone identification or stricture workup. Secondary outcomes included therapeutic success (stone extraction, stenting) and complication rate. A subgroup analysis compared previous-generation and modern cholangioscopes. We performed meta-analyses using a random-effects model and the results were reported as percentages with 95% confidence interval (CI). Results: Fourteen studies (682 patients) were eligible for analysis. The rate of diagnostic success was 98.7% (95%CI 97.6-99.8%; I2=31.19%) and therapeutic success was 88.6% (95%CI 82.8-94.3%; I2=74.92%). Adverse events were recorded in 17.1% (95%CI 10.7-23.5%; I2=77.56%), of which 15.9% (95%CI 9.8-21.9%; I2=75.98%) were minor and 0.6% (95%CI 0.1-1.2%; I2=0%) major. The Spyglass system showed null heterogeneity for all outcomes; compared with older-generation endoscopes it offered comparable diagnostic success, but yielded significantly superior therapeutic success (96.1%, 95%CI 90-100%; I2=0% vs. 86.4%, 95%CI 79.2-93.6%; I2=81.41%; P=0.02]. Conclusion: PerC, especially using currently available cholangioscopes, is associated with high diagnostic and therapeutic success.

Predictors of success of conventional ERCP for bile duct stones and need for single-operator cholangioscopy.

Background and study aims The characteristics of difficult stones requiring cholangioscopy-assisted lithotripsy are poorly defined. We sought to determine clinician perception of these characteristics and decision-making in biliary endoscopy. Methods One hundred twenty-four delegates attending an online course were invited to assess 20 clinical stone cases. Each image was graded on a 4-point Likert for: grading of stone difficulty, confidence of clearance with conventional endoscopic retrograde cholangiopancreatography (ERCP) methods, likelihood of needing cholangioscopy-assisted lithotripsy, and confidence of clearance with one session of lithotripsy. An independent reviewer rated each case on largest stone size, stone number, presence of stricture distal to stone, size of stone relative to distal duct size, and acute common bile duct (CBD) angulation < 135°. Multilevel (mixed) statistical methods with a two-level model were utilized with multilevel ordinal logistic regression. Results Stone size and location, stricture and stone diameter:duct ratio impacted perceived procedural difficulty P < 0.01). Stone:duct ratio (< 50% odds ratio [OR] 0.22, P < 0.001), stricture (OR 7.26, P < 0.001) and stone location impacted confidence of clearance with conventional ERCP. Intrahepatic and cystic duct stones were least likely to engender confidence ( P < 0.01). The same factors plus CBD angulation < 135° predicted cholangioscopy requirement ( P < 0.01). Stone number did not influence procedure difficulty or cholangioscopy requirement. Strictures (OR 0.29, P < 0.001) and location, especially intrahepatic (OR 0.42, P < 0.001) impaired confidence in clearance with one cholangioscopy session. Conclusions Ductal anatomy, the presence of a stricture distal to a stone, cystic and intrahepatic stones and stones larger than the distal duct are considered by endoscopists to be significant predictors of requiring cholangioscopy-assisted lithotripsy.

PERcutaneous transhepatic CHOLangioscopy using a new single-operator short cholangioscope (PERCHOL): European feasibility study.

OBJECTIVES: A new short device for percutaneous endoscopic cholangioscopy was recently developed. However, feasibility and safety has not yet been evaluated. The aim of this study was to assess clinical success, technical success, and adverse events (AEs). METHODS: This observational multicenter retrospective study included all patients who underwent percutaneous cholangioscopy using a short cholangioscope between 2020 and 2022. The clinical success, defined as the complete duct clearance or obtaining at least one cholangioscopy-guided biopsy, was assessed. The histopathological accuracy, technical success, and the AE rate were also evaluated. RESULTS: Fifty-one patients (60 ± 15 years, 45.1% male) were included. The majority of patients had altered anatomy (n = 40, 78.4%), and biliary stones (n = 34, 66.7%) was the commonest indication. The technique was predominantly wire-guided (n = 44, 86.3%) through a percutaneous sheath (n = 36, 70.6%) following a median interval of 8.5 days from percutaneous drainage. Cholangioscopy-guided electrohydraulic lithotripsy was performed in 29 cases (56.9%), combined with a retrieval basket in eight cases (27.6%). The clinical success was 96.6%, requiring a median of one session (range 1-3). Seventeen patients (33.3%) underwent cholangioscopy-guided biopsies. There were four (7.8%) cholangioscopy-related AEs (cholangitis and peritonitis). Overall, the technical success and AE rates were 100% and 19.6%, respectively, in a median follow-up of 7 months. CONCLUSION: Percutaneous endoscopic cholangioscopy with a new short device is effective and safe, requiring a low number of sessions to achieve duct clearance or accurate histopathological diagnosis.

Impact of ERCP simulator training on early ERCP learning curves of novice trainees: a cohort study.

Background and study aim Simulator-based training has been extensively studied in training gastroduodenoscopy and colonoscopy and shown to significantly improve learning curves of novices. Data on simulator-based training in endoscopic retrograde cholangiopancreatography (ERCP) are scarce. We aimed to determine the impact of 2-day intensive hands-on simulator training on the course of the learning curve of novice trainees. Methods We conducted a prospective cohort study using a validated mechanical ERCP simulator (Boskoski-Costamagna ERCP Trainer). Six trainees were allocated to the simulation course program (SG). Each of these trainees were paired with an endoscopy trainee starting regular ERCP training at the same center who had no exposure to a simulation course program (control group; CG). The course included lectures, live ERCP demonstrations, and hands-on ERCP training to educate trainees in basic techniques related to cannulation, stent placement, stone extraction and stricture management. After the course, both the SG and CG started formal ERCP training in their respective centers. The Rotterdam Assessment Form for ERCP was used to register each performed ERCP. Simple moving average was applied to create learning curves based on successful common bile duct (CBD) cannulation. Outcomes were plotted against a historical cohort (HC). Results Thirteen trainees were included, six trainees in the SG and seven trainees in the CG, with a total of 717 ERCPs. Mean successful ERCP cannulation rate was higher for the simulator group at baseline compared to both CG and HC, 64% versus 43% and 42%, respectively. Differences became less explicit after 40 ERCPs, but persisted until a median of 75 ERCPs. Conclusions We demonstrate that 2-day hands-on simulator-based ERCP training course has a positive effect on the learning curves of ERCP trainees and should be considered an integral part of the training curricula for ERCP to develop skills prior to patient-based training.

Performance and Safety of EUS Ablation Techniques for Pancreatic Cystic Lesions: A Systematic Review and Meta-Analysis.

BACKGROUND: Pancreatic cystic lesions (PCL) represent an increasingly diagnosed condition with significant burden to patients' lives and medical resources. Endoscopic ultrasound (EUS) ablation techniques have been utilized to treat focal pancreatic lesions. This systematic review with meta-analysis aims to assess the efficacy of EUS ablation on PCL in terms of complete or partial response and safety. METHODS: A systematic search in Medline, Cochrane and Scopus databases was performed in April 2023 for studies assessing the performance of the various EUS ablation techniques. The primary outcome was complete cyst resolution, defined as cyst disappearance in follow-up imaging. Secondary outcomes included partial resolution (reduction in PCL size), and adverse events rate. A subgroup analysis was planned to evaluate the impact of the available ablation techniques (ethanol, ethanol/paclitaxel, radiofrequency ablation (RFA), and lauromacrogol) on the results. Meta-analyses using a random effects model were conducted and the results were reported as percentages with 95% confidence intervals (95%CI). RESULTS: Fifteen studies (840 patients) were eligible for analysis. Complete cyst resolution after EUS ablation was achieved in 44% of cases (95%CI: 31-57; 352/767; I2 = 93.7%), and the respective partial response rate was 30% (95%CI: 20-39; 206/767; I2 = 86.1%). Adverse events were recorded in 14% (95%CI: 8-20; 164/840; I2 = 87.2%) of cases, rated as mild in 10% (95%CI: 5-15; 128/840; I2 = 86.7%), and severe in 4% (95%CI: 3-5; 36/840; I2 = 0%). The subgroup analysis for the primary outcome revealed rates of 70% (95%CI: 64-76; I2 = 42.3%) for ethanol/paclitaxel, 44% (95%CI: 33-54; I2= 0%) for lauromacrogol, 32% (95%CI: 27-36; I2 = 88.4%) for ethanol, and 13% (95%CI: 4-22; I2 = 95.8%) for RFA. Considering adverse events, the ethanol-based subgroup rated the highest percentage (16%; 95%CI: 13-20; I2 = 91.0%). CONCLUSION: EUS ablation of pancreatic cysts provides acceptable rates of complete resolution and a low incidence of severe adverse events, with chemoablative agents yielding higher performance rates.

ERCP for bile duct stones across a national service, demonstrating a high requirement for repeat procedures.

Background and study aims Bile duct stones (BDS) represent approximately 50 % of the requirement for endoscopic retrograde cholangiopancreatography (ERCP) within most services. Significant variation in outcome rates for BDS clearance at ERCP has been reported, and endoscopy societies have set standards for expected clearance rates. The aim of this study was to analyze procedure outcomes across a national service. Patients and methods Using verified hospital episode statistics (HES) data for the National Health Service (NHS) in England, we analyzed all patients having first ERCPs for BDS from 2015 to 2017, and followed these patients for at least 2 years. Results In total 37,468 patients underwent a first ERCP for BDS, with 69.8 % undergoing only one procedure. This figure of less than 70 % of BDS cleared at first ERCP is below the Key Performance Indicators as set by the British Society of Gastroenterology (> 75 %) and the European Society of Gastrointestinal Endoscopy (> 90 %). Of 55,556 ERCPs done for BDS, 52.9 % were repeat procedures, with 11,322 patients needing multiple procedures. For hospitals performing significant numbers of ERCPs (more than 600 for BDS during the study period) patients undergoing repeat ERCPs for BDS ranged from 9 % to 50 %. Conclusions In this nationwide study, the performance at clearing BDS at first ERCP was suboptimal, with high numbers of repeat procedures required. This may have a negative impact on both patient outcomes and experience, and increase pressure on endoscopy services. Apparent variation of outcome between acute hospital care providers requires further analysis.

The role of pancreatoscopy in the diagnostic work-up of intraductal papillary mucinous neoplasms: a systematic review and meta-analysis.

BACKGROUND: Confirming the diagnosis, invasiveness, and disease extent of intraductal papillary mucinous neoplasms (IPMNs) of the pancreas is challenging. The aim of this study was to summarize the literature on the efficacy and safety of peroral pancreatoscopy (POP) in the diagnosis of IPMN, including the impact of pre- and intraoperative POP on the management of IPMN. METHODS: The EMBASE, Medline Ovid, Web of Science, Cochrane CENTRAL, and Google Scholar databases were systematically searched for articles. Eligible articles investigated cohorts of patients who underwent POP for (suspected) IPMN. RESULTS: 25 articles were identified and included in this review; with 22 of these reporting on the diagnostic yield of POP in IPMN and 11 reporting on the effect of pre- or intraoperative POP on clinical decision-making. Cannulation and observation rates, and overall diagnostic accuracy were high across all studies. Frequently reported visual characteristics of IPMN were intraductal fish-egg-like lesions, hypervascularity, and granular mucosa. Overall, the adverse event rate was 12 %, primarily consisting of post-endoscopic retrograde cholangiopancreatography pancreatitis, with a pooled rate of 10 %, mostly of mild severity. Regarding the impact of POP on clinical decision-making, POP findings altered the surgical approach in 13 %-62 % of patients. CONCLUSION: POP is technically successful in the vast majority of patients with (suspected) IPMN, has a consistently high diagnostic accuracy, but an adverse event rate of 12 %. Data on intraoperative pancreatoscopy are scarce, but small studies suggest its use can alter surgical management. Future studies are needed to better define the role of POP in the diagnostic work-up of IPMN.

Immune checkpoint inhibitor-related cholangiopathy: Novel clinicopathological description of a multi-centre cohort.

BACKGROUND AND AIMS: Cholestatic liver dysfunction is common in immune-related hepatitis (irH) during treatment with immune checkpoint inhibitors (CPI) for malignancy. We investigated the spectrum of bile duct injury and associated natural history in this cohort. METHOD: Clinical, laboratory, radiological and histopathological data in patients with evidence of bile duct injury during CPI treatment from 2018 to 2020 was collected in three tertiary hospitals. RESULTS: In this study, ten patients with confirmed bile duct disease were identified. Pembrolizumab was most commonly implicated (8/10). Median CPI cycles prior to bile duct injury was 6. Median alanine aminotransferase and alkaline phosphatase were 225 U/L and 1549 U/L respectively. Clinical jaundice was seen in 6/10 and radiological evidence of bile duct pathology in 8/10. Of five patients, who had liver biopsy, three cases (including two cases with normal MRCP) showed primary sclerosing cholangitis (PSC) like changes with periductal fibrosis. All patients were treated first-line with prednisolone following cessation of CPI, three with mycophenolate mofetil and one with tacrolimus, with clinical response in four patients. Five patients died after a mean follow-up of 27 weeks; cause of death was primarily related to progression of malignancy. CONCLUSION: Within this heterogeneous cohort, we identified that CPI-related cholangiopathy responded poorly to immunosuppression and potentially progressed to bile duct loss. Thorough radiological and histological assessment is recommended, as identification of the cholangiopathy-associated phenotype may permit more informed advice regarding prognosis. Further data is required to determine detailed immunological characterisation in order to identify individuals at an increased risk of developing cholangiopathy.

Intraductal fully covered self-expanding metal stents in the management of post-liver transplant anastomotic strictures: a UK wide experience.

Background: Fully covered intraductal self-expanding metal stents (IDSEMS) have been well described in the management of post-liver transplant (LT) anastomotic strictures (ASs). Their antimigration waists and intraductal nature make them suited for deployment across the biliary anastomosis. Objectives: We conducted a multicentre study to analyse their use and efficacy in the management of AS. Design: This was a retrospective, multicentre observational study across nine tertiary centres in the United Kingdom. Methods: Consecutive patients who underwent endoscopic retrograde cholangiopancreatography with IDSEMS insertion were analysed retrospectively. Recorded variables included patient demographics, procedural characteristics, response to therapy and follow-up data. Results: In all, 162 patients (100 males, 62%) underwent 176 episodes of IDSEMS insertion for AS. Aetiology of liver disease in this cohort included hepatocellular carcinoma (n = 35, 22%), followed by alcohol-related liver disease (n = 29, 18%), non-alcoholic steatohepatitis (n = 20, 12%), primary biliary cholangitis (n = 15, 9%), acute liver failure (n = 13, 8%), viral hepatitis (n = 13, 8%) and autoimmune hepatitis (n = 12, 7%). Early AS occurred in 25 (15%) cases, delayed in 32 (20%) cases and late in 95 (59%) cases. Age at transplant was 54 years (range, 12-74), and stent duration was 15 weeks (range, 3 days-78 weeks). In total, 131 (81%) had complete resolution of stricture at endoscopic re-evaluation. Stricture recurrence was observed in 13 (10%) cases, with a median of 19 weeks (range, 4-88 weeks) after stent removal. At removal, there were 21 (12%) adverse events, 5 (3%) episodes of cholangitis and 2 (1%) of pancreatitis. In 11 (6%) cases, the removal wires unravelled, and 3 (2%) stents migrated. All were removed endoscopically. Conclusion: IDSEMS appears to be safe and highly efficacious in the management of post-LT AS, with low rates of AS recurrence.

Reducing the environmental footprint of gastrointestinal endoscopy: European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) Position Statement.

Climate change and the destruction of ecosystems by human activities are among the greatest challenges of the 21st century and require urgent action. Health care activities significantly contribute to the emission of greenhouse gases and waste production, with gastrointestinal (GI) endoscopy being one of the largest contributors. This Position Statement aims to raise awareness of the ecological footprint of GI endoscopy and provides guidance to reduce its environmental impact. The European Society of Gastrointestinal Endoscopy (ESGE) and the European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) outline suggestions and recommendations for health care providers, patients, governments, and industry. MAIN STATEMENTS 1: GI endoscopy is a resource-intensive activity with a significant yet poorly assessed environmental impact. 2: ESGE-ESGENA recommend adopting immediate actions to reduce the environmental impact of GI endoscopy. 3: ESGE-ESGENA recommend adherence to guidelines and implementation of audit strategies on the appropriateness of GI endoscopy to avoid the environmental impact of unnecessary procedures. 4: ESGE-ESGENA recommend the embedding of reduce, reuse, and recycle programs in the GI endoscopy unit. 5: ESGE-ESGENA suggest that there is an urgent need to reassess and reduce the environmental and economic impact of single-use GI endoscopic devices. 6: ESGE-ESGENA suggest against routine use of single-use GI endoscopes. However, their use could be considered in highly selected patients on a case-by-case basis. 7: ESGE-ESGENA recommend inclusion of sustainability in the training curricula of GI endoscopy and as a quality domain. 8: ESGE-ESGENA recommend conducting high quality research to quantify and minimize the environmental impact of GI endoscopy. 9: ESGE-ESGENA recommend that GI endoscopy companies assess, disclose, and audit the environmental impact of their value chain. 10:  ESGE-ESGENA recommend that GI endoscopy should become a net-zero greenhouse gas emissions practice by 2050.

Endoscopic Management of Complex Biliary Stones.

Complex biliary stones may be challenging to remove with standard endoscopic techniques. Factors contributing to complexity include large stone size (≥15 mm), multiple stones, high stone:distal duct ratio, stones above strictures and those in difficult anatomic position. In these cases, additional techniques may be needed, such as endoscopic papillary large balloon dilatation, mechanical lithotripsy, cholangioscopic visually directed lithotripsy, and extracorporeal shockwave lithotripsy. The choice of technique depends on local expertise and resources. Cases should be planned to identify the appropriate technique to avoid multiple procedures. This article describes the factors linked to difficulty and the steps to overcome them.

Endoscopic biliary therapy in the era of bariatric surgery.

There is an increasing demand and availability of bariatric surgery, with a range of procedures performed, some leading to altered upper gastrointestinal anatomy. The patient population undergoing bariatric surgery is also at increased risk of gallstones and biliary stone disease. Endoscopy (ie, endoscopic retrograde cholangiopancreatography) is the cornerstone of management of biliary stone disease, but may be challenging after bariatric surgery. In this review the endoscopic, surgery assisted, or percutaneous options that may be considered are discussed, based on the details of surgical anatomy and available expertise.

Erratum: UK Joint Advisory Group consensus statements for training and certification in endoscopic retrograde cholangiopancreatography.

[This corrects the article DOI: 10.1055/a-1629-7540.].

UK Joint Advisory Group consensus statements for training and certification in endoscopic retrograde cholangiopancreatography.

Background and study aims Despite the high-risk nature of endoscopic retrograde cholangiopancreatography (ERCP), a robust and standardized credentialing process to ensure competency before independent practice is lacking worldwide. On behalf of the Joint Advisory Group (JAG), we aimed to develop evidence-based recommendations to form the framework of ERCP training and certification in the UK. Methods Under the oversight of the JAG, a modified Delphi process was conducted with stakeholder representation from the British Society of Gastroenterology, Association of Upper Gastrointestinal Surgeons, trainees and trainers. Recommendations on ERCP training and certification were formulated after formal literature review and appraised using the GRADE tool. These were subjected to electronic voting to achieve consensus. Accepted statements were peer-reviewed by JAG and relevant Specialist Advisory Committees before incorporation into the ERCP certification pathway. Results In total, 27 recommendation statements were generated for the following domains: definition of competence (9 statements), acquisition of competence (8 statements), assessment of competence (6 statements) and post-certification support (4 statements). The consensus process led to the following criteria for ERCP certification: 1) performing ≥ 300 hands-on procedures; 2) attending a JAG-accredited ERCP skills course; 3) in modified Schutz 1-2 procedures: achieving native papilla cannulation rate ≥80%, complete bile duct clearance ≥ 70 %, successful stenting of distal biliary strictures ≥ 75 %, physically unassisted in ≥ 80 % of cases; 4) 30-day post-ERCP pancreatitis rates ≤5 %; and 5) satisfactory performance in formative and summative direct observation of procedural skills (DOPS) assessments. Conclusions JAG certification in ERCP has been developed following evidence-based consensus to quality assure training and to ultimately improve future standards of ERCP practice.