Dig Endosc. 2021 Mar 5. doi: 10.1111/den.13965. Online ahead of print.
ABSTRACT
OBJECTIVES: A single-use duodenoscope (SUD) has been recently developed to overcome issues with 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 centres 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-year-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 (1 duodenal stricture, 1 ampullary infiltration, and 1 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 AE. 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.
PMID:33666280 | DOI:10.1111/den.13965
