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.

Post-ERCP cholecystitis: Incidence, characteristics, and outcomes from a prospective multicenter biliary endoscopy registry.

BACKGROUND AND AIMS: The incidence, risk factors, and outcomes of post-ERCP cholecystitis are poorly described. We aimed to describe cases of post-ERCP cholecystitis from a prospective multicenter registry with protocolized 30-day follow-up. METHODS: Patient- and procedure-related data from 7 centers were obtained. The primary outcome was post-ERCP cholecystitis, defined according to a Delphi-based criteria and causal attribution system. Risk factors and outcomes were described for all cases. RESULTS: Seventeen cases of post-ERCP cholecystitis were identified among 4428 patients with gallbladders undergoing ERCP between 2018 and 2023 (incidence, 0.38%; 95% confidence interval, 0.20-0.57). In ERCPs with covered metal stenting, 7 of 467 resulted in cholecystitis (incidence, 1.50%; 95% confidence interval, 0.40-2.60). Patients had symptoms at a median of 5 days (interquartile range, 5) after ERCP. Management strategies included cholecystectomy, percutaneous cholecystostomy, and endoscopic stent removal/exchange. CONCLUSIONS: Estimates of post-ERCP cholecystitis incidence can inform discussions around procedural risk.

Impact of an emergency endovascular aneurysm repair protocol on 30-day ruptured abdominal aortic aneurysm mortality.

OBJECTIVE: To characterize the longstanding impact of an emergency endovascular aneurysm repair (EVAR) protocol for ruptured abdominal aortic aneurysm (rAAA) on 30-day mortality. METHODS: All adult patients with an rAAA who underwent a surgical or endovascular intervention at a tertiary care center between March 2001 and December 2018 were evaluated. An emergency EVAR protocol was introduced in January 2004. The primary outcome was 30-day mortality, which was calculated using risk-adjusted logistic regression for the preprotocol and postprotocol periods. A risk-adjusted cumulative sum analysis examined changes in 30-day mortality after protocol implementation. RESULTS: We identified 376 patients with rAAA between 2001 and 2018 (75 preprotocol and 301 postprotocol), with a decreasing incidence of rAAA during the study period. The introduction of the protocol in 2004 was associated with increased EVAR use (63.6% vs 6.7%; P < .001). Patients managed according to the protocol were more frequently unstable (systolic blood pressure [SBP] of ≤80 mm Hg, 46.5% postprotocol vs 22.7% preprotocol; P < 0.001), with a lower average SBP (87.4 mm Hg postprotocol vs 106 mm Hg preprotocol; P < .001) and worse renal function (estimated glomerular filtration rate 61.5 mL/min postprotocol vs 83.2 mL/min preprotocol; P < .001). The risk-adjusted 30-day mortality was 23.2% with the emergency EVAR protocol, versus 35.8% preprotocol (P = .0727). A subgroup analysis demonstrated improved the 30-day mortality for unstable patients (SBP of ≤80 mm Hg) at 38.0% (vs 62.4% preprotocol introduction; P = .0190). A cumulative sum analysis demonstrated worse than expected mortality outcomes in the preprotocol period, and stability of surgical performance over 15 years after protocol introduction. CONCLUSIONS: On reflection of a 17-year experience with EVAR for rAAA, the implementation of an emergency EVAR protocol demonstrated stable surgical performance for all patients with an rAAA and evidence of improved 30-day mortality for unstable patients with an rAAA. Since the protocol introduction, EVAR has become a mainstay intervention and, despite an increase in comorbid patients, the overall incidence of rAAA is declining. EVAR should be considered the first-line intervention for the appropriate patient unstable with an rAAA.

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.

Development and validation of a patient-reported scale for tolerability of endoscopic procedures using conscious sedation.

BACKGROUND AND AIMS: Patient-reported experience measures (PREMs) assessing the tolerability of endoscopic procedures are scarce. In this study, we designed and validated a PREM to assess tolerability of endoscopy using conscious sedation. METHODS: The patient-reported scale for tolerability of endoscopic procedures (PRO-STEP) consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and either throat or anal pain. All questions are scored on a Likert scale from 0 to 10. Cronbach's alpha was used to measure internal consistency of the questions. Multivariable logistic regression was performed to assess predictors of higher scores, reported using adjusted odds ratios and confidence intervals. RESULTS: Two hundred fifty-five patients (91 colonoscopy, 73 gastroscopy, and 91 ERCP) were included. Colonoscopy was the least tolerable procedure by recall, with mean intraprocedural awareness and discomfort scores of 5.1 ± 3.8, and 2.6 ± 2.7, respectively. Consistency between intraprocedural awareness and discomfort/pain yielded an acceptable Cronbach's alpha of .71 (95% confidence interval, .62-.78). Higher use of midazolam during colonoscopy was inversely associated with an intraprocedural awareness score of 7 or higher (per additional mg: adjusted odds ratio, .23; 95% confidence interval, .09-.54). CONCLUSIONS: PRO-STEP is a simple PREM that can be administered after multiple endoscopic procedures using conscious sedation. Future work should focus on its performance characteristics in adverse event prediction.

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.

A 3-Dimensional Anatomical Education Model in Postpartum Perineal Laceration Care: A Pre-Post Intervention Study.

OBJECTIVE: The aim of this study was to investigate the effects of postpartum patients introduction to and interaction with a virtual 3-dimensional (3D) pelvic model on the self-care, knowledge, and anxiety parameters. METHODS: The model was designed from computed tomography data displaying the involvement of the levator ani in a fourth-degree perineal laceration. This 3D model was used to educate postpartum day 1 patients at the bedside. Patient data were collected using a pre and post questionnaire assessing knowledge, anxiety, and confidence in perineal wound self-care. RESULTS: Thirty-six patients were enrolled with a median age of 28.5 years (interquartile range, 31, 21.75 years) and a median parity of 1 (interquartile range, 2, 1). Patient use of the tool significantly decreased patient anxiety regarding perineal lacerations (P < 0.01) and significantly increased patient knowledge on what part of their vagina was lacerated during vaginal delivery (P < 0.01). CONCLUSIONS: Reviewing a 3D model of perineal lacerations with patients on postpartum day 1 is associated with less anxiety and increased knowledge of pelvic floor anatomy. These pilot data represent a preliminary investigation into the relations between 3D model of perineal lacerations and a range of patient outcomes.

An Expert Derived Feedforward Histology Module Improves Pattern Recognition Efficiency in Novice Students.

Histology is a visually oriented, foundational anatomical sciences subject in professional health curricula that has seen a dramatic reduction in educational contact hours and an increase in content migration to a digital platform. While the digital migration of histology laboratories has transformed histology education, few studies have shown the impact of this change on visual literacy development, a critical competency in histology. The objective of this study was to assess whether providing a video clip of an expert's gaze while completing leukocyte identification tasks would increase the efficiency and performance of novices completing similar identification tasks. In a randomized study, one group of novices (n = 9) was provided with training materials that included expert eye gaze, while the other group (n = 12) was provided training materials with identical content, but without the expert eye gaze. Eye movement parameters including fixation rate and total scan path distance, and performance measures including time-to-task-completion and accuracy, were collected during an identification task assessment. Compared to the control group, the average fixation duration was 13.2% higher (P < 0.02) and scan path distance was 35.0% shorter in the experimental group (P = 0.14). Analysis of task performance measures revealed no significant difference between the groups. These preliminary results suggest a more efficient search performed by the experimental group, indicating the potential efficacy of training using an expert's gaze to enhance visual literacy development. With further investigation, such feedforward enhanced training methods could be utilized for histology and other visually oriented subjects.