Role of balloon-assisted cholangioscopy in a multiethnic cohort to assess complex biliary disease (with videos).

Cholangioscopy is used to diagnose and treat various biliary lesions. Balloon-assisted cholangioscopy (BAC) has mostly been reported in Asian patients with large bile ducts. To assess the feasibility and accuracy of performing BAC in complex biliary diseases in Australian patients. Prospective observational study. A single Australian tertiary referral hospital. Fifty-nine consecutive patients (55 non-Asian ethnicity). BAC using ultrathin endoscopes. Procedural success rates, diagnostic accuracy, and adverse event rates. Fifty-nine patients underwent 76 BAC procedures for indeterminate biliary lesions, ampullary adenomas, and difficult stone disease. The technical success rate was 93%. The median bile duct diameter was 7 mm (range, 2-20). Of 34 indeterminate biliary strictures, 22 appeared benign and 12 malignant on BAC appearance alone. All benign-appearing strictures were confirmed benign, whereas 9 of 12 malignant-appearing strictures were confirmed malignant by biopsy sampling or follow-up (sensitivity 100% [95% CI, 66%-100%], specificity 88% [95% CI, 69%-97%], positive predictive value 75% [95% CI, 42%-93%], negative predictive value 100% [95% CI, 82%-100%]). BAC appearance correctly diagnosed indeterminate masses as benign (4/4) or malignant (3/3). Eight patients were assessed for bile duct extension of ampullary adenomas and 5 of 6 had biliary stones cleared directly or with holmium laser lithotripsy. Adequate histopathologic specimens were obtained from 31 of 39 (79%) attempted biopsy specimens. The adverse event rate was 8%. A single-center, single endoscopist experience. In a largely non-Asian cohort with smaller bile ducts, BAC can be performed with high success and acceptable adverse event rates. BAC is particularly useful in differentiating benign from malignant indeterminate biliary lesions.