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

Of the 250 patients randomized, 126 were assigned to ERC and 124 to DSC. The mean age was 52.0 years, and 100 (40.0%) patients were male. On an intention-to-treat basis, complete stone clearance was achieved in 112 patients (88.9%) undergoing ERC, and in 108 patients (87.1%) undergoing fluoroscopy-free DSC (between-group difference, 1.8%; 1-sided upper limit of 95% CI, 8.9%; noninferiority margin 10.0%; P = .029 for noninferiority). For ERC versus DSC, the median dose area product was 2106 versus 0 Gy cm2, 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).