L L Lehrskov1, M Westen2, S S Larsen2, A B Jensen3, B B Kristensen4, T Bisgaard5. 1. Gastrounit, Surgical Section, Centre for Surgical Research, Hvidovre Hospital, University of Copenhagen, Køge, Denmark. 2. Gastrounit, Surgical Section, Køge, Denmark. 3. Radiology Section, Køge, Denmark. 4. Ambulatory Surgery Department, Hvidovre Hospital, Hvidovre, Denmark. 5. Surgical Department, Zealand University Hospital, Køge, Denmark.
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 cholangiographyduring 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).
RCT Entities:
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).
Authors: Mihai-Calin Pavel; Mar Achalandabaso Boira; Yasir Bashir; Robert Memba; Erik Llácer; Laia Estalella; Elisabeth Julià; Kevin C Conlon; Rosa Jorba Journal: Syst Rev Date: 2022-03-03
Authors: Andrea T Fisher; Kovi E Bessoff; Rida I Khan; Gavin C Touponse; Maggie M K Yu; Advait A Patil; Jeff Choi; Christopher D Stave; Joseph D Forrester Journal: Surg Open Sci Date: 2022-08-18