Fluoroscopy-free direct solitary cholangioscopy versus endoscopic retrograde cholangiography for clearance of noncomplex biliary stones: a noninferiority randomized controlled trial

BACKGROUND AND AIMS: Endoscopic removal of noncomplex bile-duct stones is typically accomplished by endoscopic retrograde cholangiography (ERC), requiring fluoroscopy-associated radiation exposure. Fluoroscopy exposure must be limited or is unavailable for some high-risk patients. We conducted a direct comparison of the efficacy and safety of ERC versus fluoroscopy-free direct solitary cholangioscopy (DSC) for noncomplex bile-duct stone removal. METHODS: Eligible patients were aged 18 years or older with noncomplex common bile-duct or common hepatic-duct stones. The primary outcome was complete stone clearance by ERC, validated by DSC, or by fluoroscopy-free DSC, validated by ERC. Secondary outcomes included (1) radiation exposure to the patient, (2) procedure duration, and (3) device- or procedure-related serious adverse events (SAEs) reported by 30 days. RESULTS: , and the median index procedure duration was 11.9 versus 22.1 minutes, respectively. Procedure-related SAEs occurred in 5 patients (4.0%) undergoing ERC and 7 patients (5.6%) undergoing DSC. CONCLUSIONS: Clearance rates of noncomplex biliary stones and rates of SAEs were comparable for ERC versus fluoroscopy-free DSC, with lower exposure to fluoroscopy-associated radiation during DSC (ClinicalTrials.gov no. NCT03421340).