Su1513 TECHNICAL EVALUATION OF DUODENOSCOPE PERFORMANCE USING A NEWLY DEVELOPED ASSESSMENT TOOL

Outcomes in ERCP are measured mainly in terms of procedural success and complications. Recently, disposable duodenoscopes have been developed to overcome the challenges associated with reusable duodenoscope-related infections. While it is important to measure the technical performance of the newly developed disposable duodenoscope relative to conventional reusable scopes, presently, there are no objective tools to accomplish this task. To assess the reliability of newly designed assessment tool to measure the technical performance of duodenoscopes. A duodenoscope assessment tool (DAT) was developed to measure the technical performance based on three components (Table): passage and positioning at the papilla (5 measures), performing requisite technical maneuvers (11 measures) and technical features (6 measures). The DAT was reviewed for content validity by two experts and each performance component was graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). DAT also captured data on procedural indications, cannulation success rates and adverse events. The main outcome measure was to assess the internal reliability of DAT as determined by the Cronbach’s coefficient alpha, with assumption of internal reliability for scale reliability coefficient ≥0.7. The DAT evaluated the performance of conventional reusable duodenoscopes (TJF 180, Olympus America) in 745 patients who underwent ERCPs at 7 tertiary medical centers over a 6-month period. Procedural indications were biliary pathology in 90.2% and pancreatic pathology in 9.8%. The median number of cannulation attempt was 1 (IQR 1-4) with overall cannulation rate of 98.1%. Adverse events included bleeding in 17 (2.3%), perforation 3 (0.4%), acute pancreatitis 18 (2.4%), infection 3 (0.4%). The summary scores for each performance measure are listed in the Table. Internal reliability was observed for all three components of DAT with scale reliability coefficients >0.7 (scale reliability coefficient of 0.82 for passage and positioning at the papilla, 0.88 for performance of requisite maneuvers and 0.93 for evaluation of technical aspects). The newly developed DAT represents a reliable measure of the performance of a duodenoscope in patients undergoing ERCP. DAT will potentially enable the objective comparison of duodenoscope performances and provide a framework for technical evaluation of other types of endoscopes.