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

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.

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.

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.

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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).