Objectives: A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study.
Methods: All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis.
Results: Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related.
Conclusions: The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.
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http://dx.doi.org/10.1111/den.13965 | DOI Listing |
Gastrointest Endosc
October 2024
Division of Gastroenterology and Hepatology, Stanford University Medical Center, Stanford, California, USA.
World J Surg
September 2024
Division of Thoracic Surgery, Department of Surgery, Hackensack Meridian Health Network, Edison, New Jersey, USA.
Background: Healthcare systems contribute 5%-10% of the global carbon footprint. Given the detrimental impact of climate change on population health, health systems must seek to address this environmental responsibility. This is especially relevant in the modern era of minimally invasive procedures (MIP) where single-use instruments are increasingly popular.
View Article and Find Full Text PDFEndoscopy
September 2024
Gastroenterology and Endoscopy / IIS La Fe, La Fe University and Polytechnic Hospital, Valencia, Spain.
Background: Infection outbreaks associated with contaminated reusable duodenoscopes (RUDs) have induced the development of novel single-use duodenoscopes (SUDs). This study aimed to analyze the material composition and life cycle assessment (LCA) of RUDs and SUDs to assess the sustainability of global and partial SUD implementation.
Methods: A single-center study evaluated material composition analysis and LCA of one RUD and two SUDs from different manufacturers (A/B).
Surg Laparosc Endosc Percutan Tech
June 2024
Department of Surgery, Division of Bariatric and Metabolic Surgery, University of South Florida, Tampa, FL.
Objective: Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes.
View Article and Find Full Text PDFJ Clin Gastroenterol
December 2024
Department of Gastroenterology and Hepatology, Mount Sinai South Nassau, Oceanside, NY.
Endoscopic retrograde cholangiopancreatography (ERCP) is the gold standard in the endoscopic management of biliary disease. An average of 700,000 ERCPs are performed every year, and most are performed using a reusable flexible duodenoscope. The innovation of disposable duodenoscopes has changed the dynamic in the advanced endoscopy field of study to primarily reduce or eliminate the risk of cross-contamination between patients.
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