DIGITAL-SINGLE-OPERATOR PERORAL CHOLANGIOSCOPY GUIDED BIOPSY VS. ERCP GUIDED BRUSHING FOR INDETERMINATE BILIARY STRICTURES - A PROSPECTIVE, RANDOMIZED MULTICENTER TRIAL

Aims Accurate diagnosis of indeterminate biliary strictures is challenging but important for patient prognostication and further management. Biopsy under direct cholangioscopic vision might be superior to standard endoscopic retrograde cholangiopancreatography (ERCP) techniques such as brushing or biopsy. Our aim was to investigate whether digital single operator cholangioscopy (DSOC) compared to standard ERCP work-up improves the diagnostic yield in patients with indeterminate biliary strictures.

Methods Patients with an indeterminate biliary stricture on the basis of MRCP were randomized to standard ERCP visualization with tissue brushing (Control Arm, CA) or DSOC visualization and DSOC guided biopsy (Study Arm, SA). This was a prospective international multicenter trial with a procedure blinded pathologist.

Results First sample sensitivity of DSOC guided biopsies was significantly higher than ERCP guided brushing (SA 68.2% vs CA 21.4%, P< 0.01). The sensitivity of visualization (SA 95.5% vs. CA 66.7%; P=0.02) and overall accuracy (SA 87.1% vs. CA 65.5%, P=0.05) were significantly higher in the SA compared to the CA while specificity, positive predictive value, and negative predictive value showed no significant difference. Adverse events were equally low in both arms.

Conclusions DSOC guided biopsies were shown to be safe and effective with a higher sensitivity compared to standard ERCP techniques in the visual and histopathological diagnosis of indeterminate biliary strictures.