Fluorescence or X-ray cholangiography in elective laparoscopic cholecystectomy: a randomized clinical trial

Abstract

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).

Response to: Meticulous surgical technique cannot be replaced by cholangiography

“…We appreciate and thank Mroczkowski and Dziki for their valuable comments and interest in our recent trial. We agree completely that cholangiography (X‐ray or fluorescent) cannot replace a careful surgical technique.…”

Application of near-infrared fluorescent cholangiography using indocyanine green in laparoscopic cholecystectomy

“…22 Hence, ICG has very high safety. 3,25 Lehrskov et al 26 recently conducted a noninferiority blinded randomized controlled trial of patients who underwent either intraoperative fluorescence cholangiography (n ¼ 60) or X-ray cholangiography (n ¼ 60) during elective LC. The authors concluded that fluorescence cholangiography was noninferior to X-ray cholangiography in visualizing the critical junction during LC.…”

Systematic Review Protocol. Near Infra-Red Indocyanine Green Fluorescent Cholangiography Versus Intraoperative Cholangiography to Improve Safety in Laparoscopic Cholecystectomy for Gallstone Disease – A Systematic Review Protocol.

“…NIR-ICG has been shown to be useful in identifying biliary structures in LC, however, its role in bile duct detection and prevention has not been established. The results reported from prior studies have mostly concluded that NIR-ICG improves visualisation of biliary structures; however, these studies included a relatively small sample size, ranging between 23 and 120 patients (36,38). Several groups(39-41) have found NIR-ICG to be feasible, although it has not been validated against IOC, which is the standard for visualisation of the critical junction.…”