BACKGROUND: Safe laparoscopic cholecystectomy may necessitate biliary imaging, and non-invasive fluorescence cholangiography may have advantages over contrast X-ray cholangiography. This trial compared fluorescence and X-ray cholangiography for visualization of the critical junction between the cystic, common hepatic and common bile ducts.
METHODS: This non-inferiority blinded RCT included patients who had either intraoperative fluorescence cholangiography using 0·05 mg/kg indocyanine green or X-ray cholangiography during elective laparoscopic cholecystectomy.
RESULTS: Between March 2015 and August 2018, a total of 120 patients were randomized (60 in each group). There were no drop-outs and 30-day follow-up data were available for all patients. In intention-to-treat analysis, there was no difference between the fluorescence and X-ray cholangiography groups in ability to visualize the critical junction (49 of 60 versus 51 of 60 respectively; P = 0·230). Fluorescence cholangiography was faster by a few minutes: median 2·0 (range 0·5-5·0) versus 4·8 (1·3-17·6) min (P < 0·001).
CONCLUSION: Fluorescence cholangiography was confirmed to be non-inferior to X-ray cholangiography in visualizing the critical junction during laparoscopic cholecystectomy. Registration number: NCT02344654 ( http://www.clinicaltrials.gov).