Incidence, Predictors, and Outcomes of Clinically Significant Post-ERCP Bleeding: a Contemporary Multi-center Study.

BACKGROUND AIMS: Clinically significant post-endoscopic retrograde cholangiopancreatography (ERCP) bleeding (CSPEB) is common. Contemporary estimates of risk are lacking. We aimed to identify risk factors for and outcomes following CSPEB. METHODS: We analyzed multi-center prospective ERCP data between 2018-2023 with 30-day follow-up. The primary outcome was CSPEB, defined as hematemesis, melena, or hematochezia resulting in: hemoglobin drop ≥20 g/L or transfusion and/or endoscopy to evaluate suspected bleeding, and/or unplanned healthcare visitation and/or prolongation of existing admission. Firth logistic regression was employed. P-values <0.05 were significant, with odds ratios (ORs) and 95% confidence intervals reported. RESULTS: CSPEB occurred following 129 (1.5%) of 8,517 ERCPs (mean onset 3.2 days), with 110 of 4,849 events (2.3%) occurring following higher-risk interventions (sphincterotomy, sphincteroplasty, pre-cut sphincterotomy, and/or needle-knife access). CSPEB patients required endoscopy and transfusion in 86.0% and 53.5% of cases, respectively, with three cases (2.3%) being fatal. P2Y12 inhibitors were held for a median of 4 days (IQR 4) prior to higher-risk ERCP. Following higher-risk interventions, P2Y12 inhibitors (OR 3.33, 1.26-7.74), warfarin (OR 8.54, 3.32-19.81), dabigatran (OR 13.40, 2.06-59.96), rivaroxaban (OR 7.42, 3.43-15.24) and apixaban (OR 4.16, 1.99-8.20) were associated with CSPEB. Significant intraprocedural bleeding post sphincterotomy (OR 2.32, 1.06-4.60), but not post sphincteroplasty, was also associated. Concomitant cardiorespiratory events occurred more frequently within 30 days following CSPEB (OR 12.71, 4.75-32.54). CONCLUSIONS: Risks of antiplatelet-related CSPEB may be underestimated by endoscopists based on observations of suboptimal holding before higher-risk ERCP. Appropriate periprocedural antithrombotic management is essential and could represent novel quality initiative targets.

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.

Characteristics and Outcomes of ERCP at a Canadian Tertiary Centre: Initial Results from a Prospective High-Fidelity Biliary Endoscopy Registry.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is an essential procedure in the management of pancreatic and biliary disease. While its role is firmly established, further well-designed prospective ERCP research is required, as a large portion of previous work has employed retrospective or administrative methodologies, both prone to potential biases. The aim of the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE) is to be a high-fidelity prospective multicentre registry. METHODS: The study population consisted of consecutive adult ERCP patients from September 2018 to September 2019. Informed consent was acquired for each patient. All relevant preprocedural, procedural, peri-procedural and postprocedural data were captured in real time by a full-time third-party research assistant directly observing procedures. Outcomes were ascertained by comprehensive medical record review and patient phone interview 30 days after the index procedure. RESULTS: Five endoscopists performed 895 ERCP procedures, 90.1% of which were deemed successful. Suspected choledocholithiasis was the most common indication for ERCP, followed by suspected or confirmed stricture(s), at 61.0% and 29.5%, respectively. 61.0% of procedures were performed on ERCP-naive patients. Post-ERCP pancreatitis occurred following 4.9% of procedures, with clinically significant bleeding or perforation occurring following 1.8% and 0.1% of procedures, respectively. DISCUSSION: Through 12 months, CReATE captured 895 procedures prospectively, with each entry containing over 300 data fields. Active expansion to additional tertiary centres is underway, and this will enhance the existing data pool. CReATE has the potential to improve multiple facets of ERCP, including training, optimal procedural techniques, mitigation of adverse events and personalized patient care.

Endosonography-guided transmural drainage of pancreatic fluid collections: comparative outcomes by stent type.

BACKGROUND: Pancreatic fluid collections (PFCs), including walled-off necrosis (WON), are commonly described sequelae of pancreatitis. Endosonography-guided PFC drainage can be performed using plastic stents (PS), fully covered self-expanding metal stents (FCSEMS), or lumen-apposing metal stents (LAMS). We performed a retrospective study comparing clinical outcomes and adverse events by stent type. METHODS: In this historical cohort, patients undergoing endosonography-guided PFC drainage from 2010 to 2019 were divided into groups: those treated with (1) PS, (2) FCSEMS, and (3) LAMS. Clinical success, the primary outcome, was defined as complete resolution or size reduction of ≥ 50%, with resolution of symptoms and no reintervention required at 3 months following the index procedure. Adverse events (AEs) and procedure times were also evaluated. RESULTS: Fifty-eight patients were included. Procedure times were significantly shorter with LAMS (21.4 ± 10.8 min versus 53.0 ± 24.4 min for FCSEMS and 65.9 ± 23.4 min for PS, p < 0.001). Clinical success rates for WON were higher with LAMS compared with FCSEMS (95.7% vs 66.7%, respectively; p = 0.04). For all PFCs, treatment with LAMS trended towards higher clinical success rates compared with PS and FCSEMS (96.3% vs 81.8% vs 77.8%, respectively; p = 0.14). Early AEs (within 1 week) occurred at significantly lower rates in the LAMS group compared to PS and FCSEMS (0% vs 33.3% vs 10.6%, respectively; p = 0.006), as did late AEs (7.4% vs 44.5% vs 40%, respectively; p = 0.01). CONCLUSIONS: LAMS is superior in terms of WON clinical success, favorable in terms of lower adverse event profile, and shorter in terms of procedural time compared to FCSEMS and PS. LAMS can be considered as an initial approach for WON, given that clinical success in WON is lower when using PS or FCSEMS, though more high-quality data are needed.

Morphology of the major papilla predicts ERCP procedural outcomes and adverse events.

BACKGROUND: The morphology of the major papilla affects the difficulty of endoscopic retrograde cholangiopancreatography (ERCP), but no associations with adverse events have previously been established. We aimed to assess whether papillary morphology predicts ERCP adverse events. METHODS: A retrospective analysis was performed of a prospective registry of patients undergoing ERCP for biliary indications. The primary outcome was post-ERCP pancreatitis (PEP), with secondary outcomes including other adverse events and procedural outcomes such as inadvertent pancreatic duct cannulation, cannulation time, and attempts. Papillae were classified as normal (Type I), small or flat (Type II), bulging (Type IIIa), pendulous (Type IIIb), creased (Type IV), or peri-diverticular (Type D). Outcomes were ascertained prospectively at 30 days from index procedures. RESULTS: A total of 637 patients with native papillae were included. Compared to Type I papillae, Type II and Type IIIb papillae were associated with PEP, with adjusted odds ratios (AOR) of 7.28 (95% confidence intervals, CI, 1.84-28.74) and 4.25 (95% CI 1.26-14.32), respectively. Type II and IIIb papillae were associated with significantly longer cannulation times by 5.37 (95% CI 2.39-8.35) and 4.01 (95% CI 1.72-6.30) minutes, respectively. Type IIIb papillae were associated with lower deep cannulation success (AOR 0.17, 95% CI 0.06-0.48). CONCLUSION: Papillary morphology is an important factor influencing both ERCP success and outcomes. Understanding this is key for managing intraprocedural approaches and minimizing adverse events. PROSPECTIVE REGISTRY REGISTRATION: Clinicaltrials.gov identifier NCT04259580.

Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial.

BACKGROUND: Endoscopic retrograde cholangio-pancreatography (ERCP) is commonly performed in the management of pancreatic and biliary disease. Duodenoscopes are specialized endoscopes used to perform ERCP, and inherent to their design, a high rate of persistent bacterial contamination exists even after automated reprocessing and disinfection. Consequently, in recent years, ERCP has been associated with infection transmission, leading to several fatal patient outbreaks. Due to increasing fears over widespread future duodenoscope-related outbreaks, regulatory bodies have called for alterations in the design of duodenoscopes. A duodenoscope has recently been developed that employs a disposable cap. This novel design theoretically eliminates the mechanism behind persistent bacterial contamination and infection transmission. However, there are no data demonstrating persistent bacterial contamination rates, technical success rates, or clinical outcomes associated with these duodenoscopes. METHODS: A parallel arm randomized controlled trial will be performed for which 520 patients will be recruited. The study population will consist of consecutive patients undergoing ERCP procedures for any indication at a high-volume tertiary care centre in Calgary, Alberta, Canada. Patients will be randomized to an intervention group, that will undergo ERCP with a novel duodenoscope with disposable cap, or to a control group who will undergo ERCP with a traditional duodenoscope. Co-primary outcomes will include persistent bacterial contamination rates (post automated reprocessing) and ERCP technical success rates. Secondary outcomes include clinical success rates, overall and specific early and late adverse event rates, 30-day mortality and healthcare utilization rates, procedure and reprocessing times, and ease of device use. DISCUSSION: The ICECAP trial will answer important questions regarding the use of a novel duodenoscope with disposable cap. Specifically, persistent bacterial contamination, technical performance, and relevant clinical outcomes will be assessed. Given the mortality and morbidity burden associated with ERCP-related infectious outbreaks, the results of this study have the capacity to be impactful at an international level. TRIAL REGISTRATION: This trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.

HCC complicated by PVT: Outcome and the role of anticoagulation therapy.

Background: This retrospective study investigated the clinical impact of PVT on the course of patients with HCC who were and were not treated with anticoagulation (AC). Methods: We retrospectively evaluated a cohort of 60 patients diagnosed with HCC and PVT. Nine patients were excluded for lack of follow-up. HCC, PVT diagnosis, and imaging follow-up were performed using contrast-enhanced computed tomography or MRI. Of the 51 patients evaluated, 12 received AC and 39 did not. Results: Forty-two patients were male; mean age was 60.3 years. Mean survival after HCC diagnosis was 32.9 months; after PVT diagnosis, it was 18.4 months. No symptoms directly related to PVT development were reported. AC therapy was initiated for 12 patients and had to be discontinued for 3 patients because of complications. AC was not associated with a difference in PVT progression (49% in non-AC group vs. 50% in AC group). After adjusting for age, HCC type (single vs. multifocal), and Child-Pugh score, AC was associated with an improved survival after HCC diagnosis (adjusted hazard ratio [HR] = 0.37; 95% confidence interval [CI] 0.14 to 0.99) and after PVT diagnosis (HR = 0.34; 95% CI 0.13 to 0.88). Conclusion: Patients with HCC complicated by PVT in both AC and non-AC groups had a similar rate of progression. Neither group had symptoms attributable to PVT. Possible AC-related complications need to be considered before proceeding with therapy in patients with HCC and PVT. AC may be associated with a survival advantage in patients with HCC and PVT.