Effectiveness of a Fluid-Collection Device for the Duodenoscope Biopsy Channel During Endoscopic Retrograde...

Background and Objectives: Fluid leakage through the biopsy port during endoscopic retrograde cholangiopancreatography (ERCP) is a common procedural challenge that can compromise efficiency and increase the risk of contamination. In this study, we aimed to evaluate factors associated with fluid leakage and describe the performance of a novel leakage-collection device. Materials and Methods: A total of 183 patients who underwent ERCP between June and September 2024 at a single center were included. Fluid leakage was measured using a prototype collection device. Patients were categorized into low- (n = 126) and high-leakage (n = 57) groups based on the mean leakage volume. Logistic regression models were used to identify the clinical and procedural factors associated with high leakage. Results: Higher procedural complexity (Schutz grade) was strongly associated with high leakage (OR per grade increase, 3.66; 95% CI, 2.33-6.07; p < 0.001). In multivariable analysis, prolonged procedure duration (aOR, 1.11; 95% CI, 1.06-1.17) and more frequent duodenal flushing (aOR, 5.38; 95% CI, 1.80-18.75) were independently associated with high fluid leakage. Biliary plastic stenting (aOR, 4.53; 95% CI, 1.54-14.69) and malignancy (aOR, 3.02; 95% CI, 1.13-8.39) also showed significant associations. The device collected a mean fluid volume of 11 mL per procedure. Conclusions: Prolonged procedure duration and frequent duodenal flushing were key predictors of increased fluid leakage during ERCP. The leakage-collection device enabled measurement and containment of biopsy-port fluid but requires further validation to determine its broader clinical utility.