Dataset Information

Use of a novel single-use disposable duodenoscope for ERCP: selected clips from a real-world case series.

ABSTRACT:

Background and aims

Single-use/disposable duodenoscopes represent one strategy to decrease the risk of patient infection related to ERCP. A preliminary case series was performed to demonstrate the feasibility and performance of a new single-use duodenoscope in a real-world clinical setting.

Methods

A single expert endoscopist performed ERCP for standard indications using a single-use duodenoscope.

Results

Videos of several key steps of ERCP obtained from 4 patients are shown to demonstrate that these steps can successfully be performed using the new single-use device. Clip 1 shows a patient with a large pancreatic duct stone in whom the image quality and maneuverability are demonstrated. Clip 2 shows a patient with choledocholithiasis and demonstrates bile duct cannulation, cholangiography, and sphincterotomy. Clip 3 shows a patient with acute cholecystitis and choledocholithiasis who underwent bile duct cannulation, sphincterotomy, and balloon sweeps. Clip 4 shows a patient with a history of liver transplant and refractory biliary anastomotic stricture who presented with abnormal liver tests and fever and underwent removal of a metal stent and placement of plastic stents.

Conclusions

A single-use duodenoscope can successfully accomplish fundamental steps of ERCP. This device can potentially eliminate the risk of patient-to-patient infections linked to contaminated instruments. Larger studies are required to assess device performance.

SUBMITTER: Thaker AM

PROVIDER: S-EPMC7732721 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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.DiscussionThe 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.