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

<i>Background and Objectives</i>: 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. <i>Materials and Methods</i>: 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- (<i>n</i> = 126) and high-leakage (<i>n</i> = 57) groups based on the mean leakage volume. Logistic regression models were used to identify the clinical and procedural factors associated with high leakage. <i>Results</i>: Higher procedural complexity (Schutz grade) was strongly associated with high leakage (OR per grade increase, 3.66; 95% CI, 2.33-6.07; <i>p</i> < 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. <i>Conclusions</i>: 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.