Clinical Efficacy and Infection Risk of ERCP Using a Novel Duodenoscope With a Disposable Cap: a Randomized Controlled Trial

There are two co-primary objectives of this study; the first is to determine the clinical efficacy of a novel duodenoscope with a disposable elevator cap (DECTM) system compared with a duodenoscope with a traditional design. The second is to determine the rate of persistent pathogenic contamination of the novel duodenoscope following standardized disinfection and reprocessing protocols, compared with a traditional duodenoscope.

This is a prospective, consecutive, randomized controlled study which will assess 1) the clinical efficacy of DEC versus standard duodenoscopes and 2) the persistent bacterial contamination rate of DEC versus standard duodenoscopes. The intervention arm will comprise use of the ED34-i10T2 duodenoscope with DEC, along with any required standard ERCP accessories, whereas the control arm will comprise use of the ED34-i10T duodenoscope with any required ERCP accessories. The study will take place at a single high-volume tertiary ERCP referral center in Calgary, Alberta, Canada, where over 1,500 ERCPs are performed annually. All procedures will be performed by trained endoscopists having each performed over 1,000 ERCPs or by advanced therapeutic endoscopy trainees under direct supervision of the expert endoscopists.

All consecutive patients at the study center who meet the eligibility criteria below will be invited for participation in the study. Patients who sign the informed consent form will be considered enrolled. In cases where it is determined that the patient failed to meet the eligibility criteria after the patient has agreed to participate in the study and/or has signed the informed consent, the study personnel will complete screening forms as well as indicate the specific inclusion/exclusion criterion that was not met. Such a patient will be considered a screen failure and will not count towards the final analyses.

Patients fulfilling the inclusion/exclusion criteria above will be randomized following consent in a 1:1 ratio. Permuted block randomization will be utilized in blocks of 8 patients. Allocation will be to one of two groups: 1) ERCP using ED34-i10T2 duodenoscope with DEC or 2) ERCP using a conventional duodenoscope (ED34-i10T). Confidential random number allocation will be accessed via a secure internet software. The study investigators, outcome adjudicators and patients will be blinded to allocation. The endoscopist will not be blinded. In cases where additional or alternate duodenoscope(s) is/are required to achieve the desired goal of the ERCP procedure, the choice(s) of device(s) will be left to the discretion of the endoscopist, regardless of the study arm to which the patient has been allocated.

The investigators have previously designed and implemented the Calgary Registry for Advanced and Therapeutic Endoscopy (CReATE, University of Calgary Conjoint Health Research Ethics Board 18-0410). CReATE is a high-fidelity prospective database that seeks to answer questions in ERCP outcomes research. As such, over 400 data fields are collected in real-time for each ERCP procedure, including detailed patient-, endoscopist- and procedure-based variables. Therefore, CReATE serves as the ideal data collection platform for this prospective randomized trial.