Subhas Banerjee, Mahesh K. Goenka, Mohan Ramchandani, Raj J. Shah, Sundeep Lakhtakia, Wiriyaporn Ridtitid, Janak Shah, Nirav Thosani, Mihir S. Wagh, Guido Costamagna, Joyce Peetermans, Matthew Rousseau, Rungsun Rerknimitr
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).