The use of Indocyanine Green (ICG) in laparoscopic cholecystectomy
Research type
Research Study
Full title
Near-infrared Fluorescence Cholangiography assisted Laparoscopic Cholecystectomy versus Conventional Laparoscopic Cholecystectomy (FALCON trial); a multicenter randomized controlled trial.
IRAS ID
232055
Contact name
Nienke Warnaar
Contact email
Sponsor organisation
Department of Surgery, Maastricht University Medical Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Several clinical feasibility studies have shown the potential benefit of near-infrared fluorescence (NIRF) imaging using Indocyanine Green (ICG) for enhanced (and quicker) biliary anatomy visualization during laparoscopic cholecystectomy with the aim to reduce the number of vascular and biliary injuries.
Wide clinical acceptance of this new technique is however still lacking, due to the absence of sufficient evidence-based data. Although the incidence of injuries is low (0.7%), the impact on patients in terms of morbidity, quality of live and costs are dramatic. Due to the low incidence, clinical studies which aim to reduce the number of injuries are impractical to carry out based on the number of patients needed to be randomized.The Critical View of Safety (CVS) technique is regarded as the safety valve in conventional laparoscopic cholecystectomy (CLC). In pilot studies NIRF-guided identification of the CVS showed to be a promising endpoint.
It is hypothesized that standard application of near-infrared fluorescence imaging during laparoscopic cholecystectomy can be useful to obtain establishment of Critical View of Safety (at least 5 minutes) earlier and with more certainty regarding visualization increasing safety when compared to conventional laparoscopic imaging alone.REC name
London - Fulham Research Ethics Committee
REC reference
18/LO/0065
Date of REC Opinion
29 Mar 2018
REC opinion
Further Information Favourable Opinion