Fluorescence versus X-ray cholangiography during laparoscopic cholecystectomy: protocol for a randomised trial.

INTRODUCTION: Intraoperative fluorescent cholangiography is a novel non-invasive imaging technique to visualise the extrahepatic biliary tract during laparoscopic cholecystectomy. It has been proven feasible, fast and cost effective. Never-theless, there is only sparse data on the capacity of fluorescent cholangiography to visualise the biliary anatomy. METHODS: Based on a non-inferiority design, patients with complicated gallstone disease are randomised to either -intraoperative conventional X-ray cholangiography (reference group, n = 60) or intraoperative fluorescent cholangiography (n = 60). The primary outcome is visualisation of the junction between the cystic duct, the common hepatic duct and the common bile duct. CONCLUSION: The present study may show that fluorescent cholangiography is as valid for visualisation of important structures of the extrahepatic biliary tract as conventional X-ray cholangiography. This may lead to the introduction of online imaging of the extrahepatic tract during dissection of the gallbladder during cholecystectomy. FUNDING: none. TRIAL REGISTRATION: This study was registered with clinicaltrials.gov (No. NCT02344654), with the National Committee on Health Research Ethics (Reg. no. H-15000817) and with the Danish Data Protection Agency (Reg no. AHH- 2015-005).