Defining failure of endoluminal biliary drainage in the era of endoscopic ultrasound and lumen apposing metal stents.

The role of endoscopy in pathologies of the bile duct and gallbladder has seen notable advancements over the past two decades. With advancements in stent technology, such as the development of lumen-apposing metal stents, and adoption of endoscopic ultrasound and electrosurgical principles in therapeutic endoscopy, what was once considered endoscopic failure has transformed into failure of an approach that could be salvaged by a second- or third-line endoscopic strategy. Incorporation of these advancements in routine patient care will require formal training and multidisciplinary acceptance of established techniques and collaboration for advancement of experimental techniques to generate robust evidence that can be utilized to serve patients to the best of our ability.

Forgotten Biliary Plastic Stents: Complications, Management, and Clinical Outcomes.

Background and Objectives: Endoscopic biliary plastic stenting is a safe and effective temporary therapeutic modality used in various benign biliary disorders. Long-term indwelling stents for more than one year without retrieval are termed "forgotten biliary stents". In clinical practice, the forgotten stents are underestimated and the majority of data were obtained from case reports. The aim of this study was to determine the forgotten-biliary-plastic-stent-related complications, their management, and the patients' clinical outcomes. Materials and Methods: This retrospective study was performed at three hospitals during the period from January 2021 to December 2023. In total, 577 patients with biliary plastic stents-inserted for a variety of benign biliary conditions-were included. They were divided into two groups, as follows: group 1 included 527 patients who had biliary stents removed within 3 months, and group 2 included 50 patients with biliary stents retrieved after one year of their deployment. The stent-related complications (e.g., acute cholangitis, stent clogging, distal stent migration, new common bile duct (CBD) stone formation, and proximal stent migration) and the endoscopic management success rate were evaluated. Results: Irretrievable CBD stones were the main indication for biliary plastic stenting in both groups. The stent-related complications, number of endoscopic sessions, and hospital admissions were significantly higher in the patients with forgotten biliary stents than those with stent removal within 3 months. All the study patients were successfully managed endoscopically with uneventful outcomes. Conclusions: Based on this retrospective study, non-adherence to the endoscopists' instructions is the main reason for retained biliary stents for more than one year. The patients with forgotten stents had significantly higher complication rates, a higher number of endoscopic sessions, and a higher number of hospital admissions than those with stents that were retrieved in the scheduled time. All patients were managed endoscopically with a technical success rate of 100%, and with no complication-related mortality.

Approaches to Pancreaticobiliary Endoscopy in Roux-en-Y Gastric Bypass Anatomy.

The increasing prevalence of bariatric surgery, particularly Roux-en-Y gastric bypass, has necessitated innovative approaches for endoscopic retrograde cholangiopancreatography (ERCP) due to the altered anatomy. Laparoscopy-assisted ERCP offers high success rates but leads to extended hospital stays and an increased risk of adverse events. Enteroscopy-assisted ERCP encounters technical challenges, resulting in lower success rates. A novel technique, endoscopic ultrasound-directed transgastric ERCP, employs a lumen-apposing metal stent to create a fistula connecting the gastric pouch to the excluded stomach, enabling ERCP and other endoscopic procedures. Common adverse events include perforation, stent migration, bleeding, and fistula persistence.

Adverse Events and Device Failures Associated with Pancreatic Stents: A Comprehensive Analysis Using the FDA's MAUDE Database.

INTRODUCTION: Pancreatic duct stents (PDS) are widely used for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. However, there is a paucity of data regarding the adverse events associated with PDS placement. This study aims to investigate the reported adverse events and device failures related to PDS, utilizing the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the U.S. Food and Drug Administration (FDA). METHODS: Post-marketing surveillance data from January 2013 to December 8, 2023, were extracted from the FDA's MAUDE database to analyze the reports pertaining to the use of commonly used PDS. The primary outcomes of interest were device issues and patient-related adverse events. Statistical analysis was performed using Microsoft Excel 2010, with the calculation of pooled numbers and percentages for each device and patient adverse event. RESULTS: A total of 579 device issues and 194 patient-related adverse events were identified. Device issues were primarily attributed to stent deformation (n = 72; 12.4%), followed by migration of the device into the pancreatic duct or expulsion out of the duct (n = 60; 10.4%), and stent fracture/breakage (n = 55; 9.4%). Among the patient-reported adverse events, inflammation was the most common (n = 26; 13.4%), followed by reports of stents becoming embedded in tissue (n = 21; 10.8%) and stent occlusion/obstruction (n = 16; 8.2%). The most prevalent device failures associated with Advanix stents were material deformation, with perforation (n = 3, 30%) being the most frequently reported adverse event. Concerning Geenen stents, migration or expulsion of the device (n = 34, 16.9%) constituted the most common device-related adverse events, while inflammation (n = 20, 16.7%) was the most frequently reported patient-related issue. For Zimmon stents, migration or expulsion of the device (n = 22, 8.8%) were the most frequently reported device-related problems, whereas perforation (n = 7, 10.9%) and bleeding (n = 7, 10.9%) were the most frequent patient-related adverse events. CONCLUSION: Our findings highlight important device and patient adverse events that endoscopists and referring providers should be aware of before considering pancreatic stent placement.

Assessment of the Learning Curve for a Single-Use Disposable Duodenoscope.

BACKGROUND AND AIMS: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. METHODS: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. RESULTS: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. CONCLUSION: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.

Successful cholangioscopy-guided cannulation using a novel slim cholangioscope.

Selective biliary cannulation is a difficult step in endoscopic retrograde cholangiopancreatography. In this case video, Tanisaka and colleagues report a successful cholangioscopy-guided cannulation achieved using a novel slim cholangioscope with a 2.3-mm scope tip. Cholangioscopy-guided cannulation using this cholangioscope could be a good option in cases of difficult biliary cannulation.

Effect of Disposable Elevator Cap Duodenoscopes on Persistent Microbial Contamination and Technical Performance of Endoscopic Retrograde Cholangiopancreatography: The ICECAP Randomized Clinical Trial.

Importance: Infection transmission following endoscopic retrograde cholangiopancreatography (ERCP) can occur due to persistent contamination of duodenoscopes despite high-level disinfection to completely eliminate microorganisms on the instrument. Objective: To determine (1) contamination rates after high-level disinfection and (2) technical performance of duodenoscopes with disposable elevator caps compared with those with standard designs. Design, Setting, and Participants: In this parallel-arm multicenter randomized clinical trial at 2 tertiary ERCP centers in Canada, all patients 18 years and older and undergoing ERCP for any indication were eligible. Intervention: The intervention was use of duodenoscopes with disposable elevator caps compared with duodenoscopes with a standard design. Main Outcomes and Measures: Coprimary outcomes were persistent microbial contamination of the duodenoscope elevator or channel, defined as growth of at least 10 colony-forming units of any organism or any growth of gram-negative bacteria following high-level disinfection (superiority outcome), and technical success of ERCP according to a priori criteria (noninferiority outcome with an a priori noninferiority margin of 7%), assessed by blinded reviewers. Results: From December 2019 to February 2022, 518 patients were enrolled (259 disposable elevator cap duodenoscopes, 259 standard duodenoscopes). Patients had a mean (SD) age of 60.7 (17.0) years and 258 (49.8%) were female. No significant differences were observed between study groups, including in ERCP difficulty. Persistent microbial contamination was detected in 11.2% (24 of 214) of standard duodenoscopes and 3.8% (8 of 208) of disposable elevator cap duodenoscopes (P = .004), corresponding to a relative risk of 0.34 (95% CI, 0.16-0.75) and number needed to treat of 13.6 (95% CI, 8.1-42.7) to avoid persistent contamination. Technical success using the disposable cap scope was noninferior to that of the standard scope (94.6% vs 90.7%, P = .13). There were no differences between study groups in adverse events and other secondary outcomes. Conclusions and Relevance: In this randomized clinical trial, disposable elevator cap duodenoscopes exhibited reduced contamination following high-level disinfection compared with standard scope designs, without affecting the technical performance and safety of ERCP. Trial Registration: ClinicalTrials.gov Identifier: NCT04040504.

Efficacy of Common Bile Duct Stenting on the Reduction in Gallstone Migration and Symptoms Recurrence in Patients with Biliary Pancreatitis Who Were Candidates for Delayed Cholecystectomy.

BACKGROUND: In patients with severe biliary pancreatitis, delayed cholecystectomy associated with a high risk of recurrence is recommended. The current study aimed to evaluate the effect of common bile duct (CBD) stenting on reducing gallstones migration and recurrence of symptoms in patients with pancreatitis and delayed cholecystectomy candidates. METHODS: To this purpose, the randomized, controlled clinical trial was performed on 40 patients with biliary pancreatitis who were candidates for delayed cholecystectomy. Patients were randomly divided into two groups of A and B that underwent CBD stenting after ERCP and received endoscopic treatment without stenting, respectively. A checklist recorded demographics and complications. Group A was followed up after four weeks to remove the stent and record the complications. Group B underwent MRCP to examine the migration of new gallstones as well as the complications. RESULTS: Of the 40 patients, 20 subjects (11 males and 9 females) were allocated to each group, matched for demographic variables. In the one-month follow-up, only one subject in group A manifested symptoms of gallstone migration and recurrence, while in group B, recurrence was observed in 6 patients (P = 0.037). There was no significant difference in the success rate of ERCP and the incidence of complications between the two groups. CONCLUSION: CBD stenting in patients with biliary pancreatitis and gallstone could reduce the risk of recurrence and remigration of gallstones in delayed cholecystectomy cases.

Colonic diverticular perforation by a migrated biliary stent: A case report with literature review.

RATIONALE: Plastic endobiliary stents, after endoscopic retrograde cholangiopancreatography, can get spontaneously dislocated from the common bile duct and migrate intothe distal bowel. Most migrated biliary stents are removed with the passing of stool. However, migrated biliary stents can cause bowel perforation, albeit rarely, and surgical intervention may be required. Recently, we observed a colonic diverticular perforation caused by a migrated biliary stent, and we have reported this case with a review of the literature. PATIENTS CONCERNS: A 74-year-old man presented with severe right lower quadrant pain after biliary stent insertion 1month ago. DIAGNOSES: Abdominal computed tomography revealed perforation of the proximal ascending colon by the migrated biliary stent, combined with localized peritonitis. INTERVENTIONS: Emergency diagnostic laparoscopic examination revealed penetration of the proximal ascending colon by the plastic biliary stent, and right hemicolectomy was performed. OUTCOMES: On pathological examination, colonic diverticular perforation by the biliary stent was confirmed. The patient was discharged without any additional complications. LESSONS: Endoscopic retrograde cholangiopancreatography endoscopists must always be cautious of the possibility of stent migration in patients with biliary stents in situ. In cases of biliary stent dislocation from the common bile duct in asymptomatic patients, follow-up with serial, plain abdominal radiographs, and physical examination is needed until confirmation of spontaneous passage through stool. In symptomatic cases suggesting peritonitis, abdominal computed tomography scan confirmation is needed, and early intervention should be considered.