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Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial

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Abstract

Aim

To assess the added value of Near InfraRed Fluorescence (NIRF) imaging during laparoscopic cholecystectomy.

Methods

This international multicentre randomized controlled trial included participants with an indication for elective laparoscopic cholecystectomy. Participants were randomised into a NIRF imaging assisted laparoscopic cholecystectomy (NIRF-LC) group and a conventional laparoscopic cholecystectomy (CLC) group. Primary end point was time to ‘Critical View of Safety’ (CVS). The follow-up period of this study was 90 postoperative days. An expert panel analysed the video recordings after surgery to confirm designated surgical time points.

Results

A total of 294 patients were included, of which 143 were randomized in the NIRF-LC and 151 in the CLC group. Baseline characteristics were equally distributed. Time to CVS was on average 19 min and 14 s for the NIRF-LC group and 23 min and 9 s for the CLC group (p 0.032). Time to identification of the CD was 6 min and 47 s and 13 min for NIRF-LC and CLC respectively (p < 0.001). Transition of the CD in the gallbladder was identified after an average of 9 min and 39 s with NIRF-LC, compared to 18 min and 7 s with CLC (p < 0.001). No difference in postoperative length of hospital stay nor occurrence of postoperative complications was found. ICG related complications were limited to one patient who developed a rash after injection of ICG.

Conclusion

Use of NIRF imaging in laparoscopic cholecystectomy provides earlier identification of relevant extrahepatic biliary anatomy: earlier achievement of CVS, cystic duct visualisation and visualisation of both cystic duct and cystic artery transition into the gallbladder.

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Funding

Unrestricted grants were received from EAES and Karl Storz for parts of the research projects.

Author information

Authors and Affiliations

  1. Department of Surgery, Maastricht University Medical Center, Maastricht, The Netherlands

    J. van den Bos, N. D. Bouvy & L. P. S. Stassen

  2. Department of Plastic, Reconstructive and Hand Surgery, Maastricht University Medical Center, Maastricht, The Netherlands

    R. M. Schols

  3. Department of Surgery, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico Di Milano, Milan, Italy

    L. Boni & E. Cassinotti

  4. Department of Surgery, Asklepios West Klinikum, Hamburg, Germany

    T. Carus

  5. Department of Surgery, Catharina Ziekenhuis, Eindhoven, The Netherlands

    M. D. Luyer

  6. Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands

    A. L. Vahrmeijer & J. S. D. Mieog

  7. Department of Surgery, Colchester General Hospital, Colchester, UK

    N. Warnaar

  8. Department of General and HPB Surgery and Liver Transplantation, University Hospital Ghent, Ghent, Belgium

    F. Berrevoet

  9. Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Rotterdam, The Netherlands

    F. van de Graaf & J. F. Lange

  10. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands

    S. M. J. Van Kuijk

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  1. J. van den Bos
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Corresponding author

Correspondence to J. van den Bos.

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Disclosure

There are no personal conflicts of interest of financial ties for the authors of this study: Dr. Jacqueline van den Bos, Dr. Rutger M. Schols, professor dr Luigi Boni, dr Elisa Cassinotti, professor dr Thomas Carus, dr Micha D. Luyer, Professor Dr. Alexander L. Vahrmeijer, Dr. Sven J.S.D. Mieog, Dr. Nienke Warnaar, Professor Dr. Frederik Berrevoet, Dr. Floyd van de Graaf, Professor Dr. Johan F. Lange, Dr. Sander M.J. Van Kuijk, Professor Dr. Nicole D. Bouvy, Professor Dr. Laurents P.S. Stassen have no conflicts of interest or financial ties to disclose.

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van den Bos, J., Schols, R.M., Boni, L. et al. Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy (FALCON): an international multicentre randomized controlled trial. Surg Endosc 37, 4574–4584 (2023). https://doi.org/10.1007/s00464-023-09935-6

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