ArticleBMC gastroenterology2020
Infection control in ERCP using a duodenoscope with a disposable cap (ICECAP): rationale for and design of a randomized controlled trial.
Article in BMC gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04040504 (Clinical Efficacy and Infection Risk of ERCP Using a Novel Duodenoscope With a Disposable Cap), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Clinical Efficacy and Infection Risk of ERCP Using a Novel Duodenoscope With a Disposable Cap: a Randomized Controlled Trial
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Meta-analysis of the effectiveness of early endoscopic treatment of Acute biliary pancreatitis based on lightweight deep learning model.BMC gastroenterology · 2024Pooled it
- Detection of Burkholderia gladioli in contaminated ultrasonic coupling agent.BMC microbiology · 2025Article
- Adverse events, success, and tolerability of biliary endoscopic retrograde cholangiopancreatography with conscious sedation vs anaesthesia: a multi-centre prospective study.Journal of the Canadian Association of Gastroenterology · 2025Article
- Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound endoscope reprocessing: Variables impacting contamination risk.Infection control and hospital epidemiology · 2023Observational
- Current Status and Future Course of Disposable-Component and Single-Use Duodenoscopes.Gastroenterology & hepatology · 2023Article
- Transmission of oral microbiota to the biliary tract during endoscopic retrograde cholangiography.BMC gastroenterology · 2023Article
- Characteristics and Outcomes of ERCP at a Canadian Tertiary Centre: Initial Results from a Prospective High-Fidelity Biliary Endoscopy Registry.Journal of the Canadian Association of Gastroenterology · 2021Article
- Pediatric ERCP with a single-use duodenoscope in an immunocompromised child.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2021Article
- Recent Advances in Endoscope Disinfection: Where Do We Stand in the COVID era?Techniques and innovations in gastrointestinal endoscopy · 2021Review
- Sterile disposable elevator cap in the reduction of cross-contamination.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2020Article
- Infection Control in Endoscopic Retrograde Cholangiopancreatography: A Human Factors Perspective.Clinical and translational gastroenterology · 2020Review
- Bilio-pancreatic endoscopy during COVID-19 pandemic.Therapeutic advances in gastroenterology · 2020Review
- Esophageal Perforation after Using a Single-Use Disposable Duodenoscope.Case reports in gastroenterologyArticle
Corrections and comments
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Authors and funding
15 authors at 2 institutions in 2 countries.
Funding
Abstract
backgroundEndoscopic 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.
methodsA 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 registrationThis trial was registered on clinicaltrials.gov (NCT04040504) on July 31, 2019.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.