Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos)

BackgroundThe feasibility of single-operator cholangioscopy (SOC) for biliary diagnostic and therapeutic procedures was previously reported.ObjectiveTo confirm the utility of SOC in more widespread clinical use.DesignProspective clinical cohort study.SettingFifteen endoscopy referral centers in the United States and Europe.PatientsTwo hundred ninety-seven patients requiring evaluation of bile duct disease or biliary stone therapy.InterventionsSOC examination and, as indicated, SOC-directed stone therapy or forceps biopsy.Main Outcome MeasurementsProcedural success defined as ability to (1) visualize target lesions and, if indicated, collect biopsy specimens adequate for histological evaluation or (2) visualize biliary stones and initiate fragmentation and removal.ResultsThe overall procedure success rate was 89% (95% CI, 84%-92%). Adequate tissue for histological examination was secured in 88% of 140 patients who underwent biopsy. Overall sensitivity in diagnosing malignancy was 78% for SOC visual impression and 49% for SOC-directed biopsy. Sensitivity was higher (84% and 66%, respectively) for intrinsic bile duct malignancies. Diagnostic SOC procedures altered clinical management in 64% of patients. Procedure success was achieved in 92% of 66 patients with stones and complete stone clearance during the study SOC session in 71%. The incidence of serious procedure-related adverse events was 7.5% for diagnostic SOC and 6.1% for SOC-directed stone therapy.LimitationsThe study was observational in design with no control group.ConclusionsEvaluation of bile duct disease and biliary stone therapy can be safely performed with a high success rate by using the SOC system.