Bertrand Napoléon1, Jean-Michel Gonzalez2, Philippe Grandval3, Andrea Lisotti1,4, Arthur E Laquière5, Christian Boustière5, Marc Barthet2, Frédéric Prat6, Thierry Ponchon7, Gianfranco Donatelli8, Geoffroy Vanbiervliet9. 1. Endoscopy Unit, Hôpital Privé Jean Mermoz, Ramsay Générale de Santé, Lyon, France. 2. Service de Gastro-entérologie, Hôpital Nord, Aix Marseille Université, Marseille, France. 3. Digestive Endoscopy and Gastroenterology Department, Hôpital de la Timone, Aix Marseille University, Marseille, France. 4. Gastroenterology Unit, Hospital of Imola, University of Bologna, Imola, Italy. 5. Departments of Hepatogastroenterology and Clinical Research, Hôpital Saint Joseph, Marseille, France. 6. Service d'Endoscopie, GHU AP-HP Nord, Université de Paris et Inserm, Paris, France. 7. Hepato-Gastroenterology Department, Edouard Herriot University Hospital, Lyon, France. 8. Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Paris, France. 9. Centre Hospitalier Universitaire de Nice, Hôpital L'Archet 2, Nice, France.
Abstract
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.
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.
Authors: Diederik Persyn; Hannah Van Malenstein; Emma Vanderschueren; Annette Schuermans; Mira Dreesen; Wouter Meert; Kristof Buysschaert; Schalk Van Der Merwe; Wim Laleman Journal: Ann Gastroenterol Date: 2022-06-02
Authors: Clara Benedetta Conti; Roberto Frego; Alessandro Ettore Redaelli; Marta Maino; Giacomo Mulinacci; Marco Emilio Dinelli Journal: Endosc Int Open Date: 2021-12-14