Abstract
BACKGROUND AND AIMS: Fluoroscopy-free endoscopic retrograde cholangiopancreatography for common bile duct stone (CBDS) clearance is usually offered only to pregnant patients. We initiated a multicenter, randomized controlled trial comparing clearance of non-complex CBDSs using fluoroscopy-free direct solitary cholangioscopy (DSC) to standard endoscopic retrograde cholangiography (ERC) to evaluate the wider applicability of the DSC-based approach. Here we report the initial results of stone clearance and safety in roll-in cases for the randomized controlled trial. METHODS: Twelve expert endoscopists at tertiary care centers in four countries prospectively enrolled 47 patients with non-complex CBDSs for DSC-assisted CBDS removal in an index procedure including fluoroscopy-free cannulation. Successful CBDS clearance was first determined by DSC and subsequently validated by final occlusion cholangiogram as the ERC gold standard. RESULTS: Fully fluoroscopy-free cannulation was successful in 42/47 (89.4%) patients. Brief fluoroscopy with minimal contrast injection was used in 4/47 (8.5%) patients during cannulation. Cannulation failed in 1/47 (2.1%) patients. Fluoroscopy-free complete stone clearance was reached in 38/46 (82.6%) cases. Residual stones were detected in the validation ERC occlusion cholangiogram in three cases. Overall serious adverse event rate was 2.1% (95% confidence interval 0.1-11.3): postprocedural pancreatitis in one patient. CONCLUSIONS: In patients with non-complex CBDS, the fluoroscopy-free technique is easily transferred to endoscopic retrograde cholangiopancreatography experts with acceptable rates of cannulation and stone clearance and few serious adverse events. (ClinicalTrials.gov number, NCT03421340).