Case Control Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jun 16, 2025; 17(6): 105298
Published online Jun 16, 2025. doi: 10.4253/wjge.v17.i6.105298
Efficacy and safety of single use duodenoscopes in comparison to reusable duodenoscopes for endoscopic retrograde cholangiopancreatography: A single center experience
Iyiad Alabdul Razzak, Maram Alenzi, Butros Fakhoury, Xin-Yuan Zhang, Krishnan Sandeep, Syed Kashif Mahmood
Iyiad Alabdul Razzak, Department of Internal Medicine, BIDMC, Harvard Medical School, Boston, MA 02115, United States
Maram Alenzi, Butros Fakhoury, Syed Kashif Mahmood, Department of Gastroenterology and Hepatology, Boston Medical Center, Boston University, Boston, MA 02135, United States
Xin-Yuan Zhang, Channing Division of Network Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, MA 02115, United States
Krishnan Sandeep, Department of Gastroenterology and Hepatology, Boston Medical Center, Boston University School of Medicine, Boston, MA 02135, United States
Co-first authors: Iyiad Alabdul Razzak and Maram Alenzi.
Author contributions: All of the authors read and approved the final version of the manuscript to be published.
Institutional review board statement: The study protocol was reviewed and by approved by the institutional review board (No. HW06-23).
Informed consent statement: Written informed consent or publication consent from the participants was not required for this retrospective study in accordance with local/national guidelines.
Conflict-of-interest statement: No conflict of interest.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Data sharing statement: Data are available from the corresponding author upon reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Syed Kashif Mahmood, MD, MPH, FASGE, Medical Director of Gastrointestinal Endoscopy, Assistant Professor, Department of Gastroenterology and Hepatology, Boston Medical Center, Boston University, 1 Silber Way, Boston, MA 02135, United States. syed.mahmood@lahey.org
Received: January 18, 2025
Revised: March 5, 2025
Accepted: May 7, 2025
Published online: June 16, 2025
Processing time: 145 Days and 0.1 Hours
Abstract
BACKGROUND

Single-use duodenoscopes (SDs) were introduced to eliminate exogenous infection risks post-endoscopic retrograde cholangiopancreatography (ERCP).

AIM

To evaluate their efficacy and safety against reusable duodenoscopes (RDs).

METHODS

This was a single-center case control study. All consecutive patients undergoing ERCP using SD between 2020 and 2023 were enrolled. A similar number of patients undergoing ERCP using RD were randomly selected and enrolled. In case of ERCP failure using SD, operators switched to a RD if judged appropriate. The primary outcome was successful ERCP completion rates. The secondary outcomes were rate of difficult biliary cannulation, incidence of crossover from SD to RD, procedure related adverse events, 30-day re-admission rate, and endoscopists' assessment of SD's performance.

RESULTS

A total of 133 patients were enrolled (n = 53 for SD, n = 80 for RD). Baseline characteristics and American Society for Gastrointestinal Endoscopy ERCP complexity grades were comparable between both groups. Successful ERCP completion rates were 88.7% for SD and 95% for RD (P = 0.3). In cases of unsuccessful ERCP with SD, crossover to RD occurred in 3 out of 6 instances, with 2 subsequently succeeding with RD. Rates of adverse events and 30-day readmission were comparable: (1) 13.2% vs 11.2% (P = 0.19); and (2) 15.4% vs 8.9% (P = 0.25), respectively. Median overall endoscopists’ satisfaction with SD was 8 out of 10.

CONCLUSION

The novel SDs demonstrated no difference in efficacy and safety compared to conventional RDs when used to perform a wide range of ERCPs. Nevertheless, further development and study of SDs’ financial and environmental effectiveness is warranted.

Keywords: Endoscopic retrograde cholangiopancreatography; Single-use duodenoscopes; Reusable duodenoscopes; Patient outcomes; Infection control

Core Tip: This study compares the efficacy and safety of single-use duodenoscopes (SDs) with reusable duodenoscopes (RDs) for performing endoscopic retrograde cholangiopancreatography (ERCP). The results showed no significant difference in successful ERCP completion rates (88.7% for SD vs 95% for RD, P = 0.3), adverse event rates, or 30-day readmission rates between the two groups. Despite slightly lower success with SDs, crossover to RD was infrequent and often successful. Endoscopists’ satisfaction with SDs was generally high. These findings suggest SDs are comparable to RDs in terms of safety and efficacy, though further studies on their cost-effectiveness are needed.