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

Background: 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.

Objective: To assess the feasibility and accuracy of performing BAC in complex biliary diseases in Australian patients.

Design: Prospective observational study.

Setting: A single Australian tertiary referral hospital.

Patients: Fifty-nine consecutive patients (55 non-Asian ethnicity).

Interventions: BAC using ultrathin endoscopes.

Main Outcome Measurements: Procedural success rates, diagnostic accuracy, and adverse event rates.

Results: 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%.

Limitations: A single-center, single endoscopist experience.

Conclusions: 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.