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.

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.

Incidence and Predictors of Incidental Biochemical and Radiologic Pancreatic Alterations Following Uncomplicated ERCP.

BACKGROUND: Despite post-ERCP pancreatitis (PEP) being a major focus of outcomes research in endoscopic retrograde cholangiopancreatography (ERCP), little is known regarding the frequency with which asymptomatic biochemical and/or radiologic pancreatic alterations occur in patients following ERCP. METHODS: Adult inpatients undergoing ERCP were identified from a prospective ERCP registry. Patients with any abdominal pain, confirmed PEP, or pancreatitis or abnormal pancreatic enzymes preceding ERCP were excluded. Primary outcomes were asymptomatic lipase elevation on bloodwork within 24 h of ERCP or asymptomatic cross-sectional imaging findings consistent with acute pancreatitis in the absence of clinical PEP within 14 days. Multinomial logistic regression and multiple logistic regression were used to examine associations between exposures and lipase levels and between PEP or imaging findings, respectively. RESULTS: In total, 646 and 187 patients were analyzed as part of the biochemical and radiologic cohorts, respectively. A total of 26.0% of patients had asymptomatic elevations in lipase above the upper limit of normal (ULN) within 24 h, and 9.4% had elevations >3× ULN. A total of 20.9% of patients had incidental findings of enlargement, inflammation/edema/fat stranding, peri-pancreatic fluid collections, and/or necrosis on cross-sectional imaging within 14 days. Pancreatic contrast injection was associated with higher odds of asymptomatic lipasemia (adjusted odds ratio, AOR, 7.22; 95% confidence intervals, CI, 1.13 to 46.02), as was the use of the double-wire technique (AOR 15.74; 95% 1.15 to 214.74) and placement of a common bile duct stent (AOR 4.19; 95% CI 1.37 to 12.77). Over 10 cannulation attempts were associated with the presence of one or more radiologic finding(s) (AOR 33.95; 95% CI 1.64, to 704.13). CONCLUSIONS: Significant rates of incidental biochemical and/or radiologic pancreatic abnormalities are present following ERCP. Clinicians should be aware of our findings to minimize misclassification and better direct healthcare utilization.

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.

Baseline Cannabinoid Use Is Associated with Increased Sedation Requirements for Outpatient Endoscopy.

Background and Aims: Given the underlying properties of cannabinoids, we aimed to assess associations between cannabinoid use and sedation requirements for esophagogastroduodenoscopy (EGD) and colonoscopy. Methods: A prospective cohort study was conducted at three endoscopy units. Adult outpatients undergoing EGD or colonoscopy with endoscopist-directed conscious sedation (EDCS) were given questionnaires on cannabinoid use and relevant parameters. Outcomes included intraprocedural midazolam, fentanyl, and diphenhydramine use, procedural tolerability, and adverse events. Multivariable logistic regression was performed to yield adjusted odds ratios (AORs) of outcomes. Results: A total of 419 patients were included. Baseline cannabinoid use was associated with high midazolam use, defined as ≥5 mg, during EGD (AOR 2.89, 95% confidence interval, CI: 1.19-7.50), but not during colonoscopy (AOR 0.89, 95% CI 0.41-1.91). Baseline cannabinoid use was associated with the administration of any diphenhydramine during EGD (AOR 3.04, 95% CI: 1.29-7.30) with a similar nonsignificant trend for colonoscopy (AOR 2.36, 95% CI: 0.81-7.04). Baseline cannabinoid use was associated with increased odds of requiring high total sedation, defined as any of midazolam ≥5 mg, fentanyl ≥100 mcg, or any diphenhydramine during EGD (AOR 3.72, 95% CI: 1.35-11.68). Cannabinoid use was not independently associated with fentanyl use, intraprocedural awareness, discomfort, or adverse events. Conclusions: Baseline cannabinoid use was associated with higher sedation use during endoscopy with EDCS, particularly with midazolam and diphenhydramine. Given increasingly widespread cannabinoid use, endoscopists should be equipped with optimal sedation strategies for this population. As part of the informed consent process, cannabis users should be counseled that they may require higher sedation doses to achieve the same effect.

Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis.

(1) Background: Various methods to predict the presence or absence of choledocholithiasis (CDL) have been proposed. We aimed to assess the performance characteristics of dynamic liver enzyme trends in the prediction of CDL. (2) Methods: This was a single-center retrospective cohort study. All adult in-patients undergoing endoscopy for suspected CDL between 1 January 2012 and 7 October 2018 were identified, with patients with prior cholecystectomy, prior sphincterotomy, or indwelling biliary prostheses were excluded. Available laboratory parameters within 72 h preceding the procedure were recorded, allowing for the assessment of trends. Dynamic enzyme trends were defined as any increase or decrease by 30% and 50% within 72 h of the index procedure. (3) Results: A total of 878 patients were included. Mean age was 61.8 years, with 58.6% female. Increases in alkaline phosphatase (ALP) of at least 30% or 50% were both specific for the presence of CDL, with specificities of 82.7% (95% CI 69.7-91.8%) and 88.5% (95% CI 76.6-95.6%), respectively. Decreases in bilirubin or ALP of at least 50% were highly specific for the absence of CDL, with specificities of 91.7% (95% CI 85.7-95.8%) and 100.0% (97.2-100.0%), respectively. (4) Conclusions: Several liver enzyme trends appear to be specific for the absence or presence of stones; in particular, significant decreases in total bilirubin or ALP of at least 30-50% over the prior 72 h appear to be especially predictive of an absence of intraductal findings during endoscopy.