Work

Value of intravenous cholangiography with indocyanine green during laparoscopic cholecystectomy for grade I or II acute lithiasic cholecystitis: Results of a prospective, open, randomized, monocentric study (VIFCAL trial)

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Background We aimed to determine whether the injection of indocyanine green (ICG) before a laparoscopic cholecystectomy for grade 1 or 2 acute lithiasic cholecystitis (ALC) allows a faster obtainment of the critical view of safety (CVS) and a reduction in operative time. Methods We performed a prospective, open, randomized, monocentric superiority trial (NCT04103762 ) with two parallel arms between 2020 and 2022 to compare intravenous ICG cholangiography and standard intraoperative cholangiography (IOC) in patients with grade 1 or 2 ALC according to the 2018 Tokyo Guidelines. The co-primary endpoint was the operative time to obtain the CVS and the total operative time during laparoscopic cholecystectomy in both groups. The secondary endpoints were visualization of the biliary structures, the feasibility of the surgical procedure, morbidity and mortality, the length of stay and side effects. We conducted a subgroup analysis to evaluate the influence of the perivesicular peritoneal thickness. We hypothesized that the use of ICG should allow a faster obtainment of the CVS and a reduction in operative time. Considering a reduction of 10 min of the dissection time for Calot’s triangle and 20 min reduction of total operative time to be clinically relevant, the number of subjects to include per group was 64. Intention-to-treat (ITT) analyze was conducted for the assessment of the two components of the primary endpoint and a per-protocol (PP) analyze was conducted for the evaluation of the total operative time. In the experimental group, additional use of the IOC procedure was left to the surgeon. Results One hundred and thirty-four patients were randomized: 66 in the experimental arm and 68 in the standard arm. In ITT analysis, ICG injection was not associated with a significant decrease in the operative time to obtain the CVS (32 min vs. 30 min, p > 0.9). The mean operative time (82 min vs. 82 min) were similar between the ICG and IOC arms. In the same way, in PP analysis, the mean operative time was similar in both groups (82 min vs 81 min). Conclusion In the conditions of this study, with its parameters (design, dosage and delay), the use of ICG during laparoscopic cholecystectomy for grade 1 or 2 ALC does not allow a reduction in the time to obtain the CVS neither in the operative time. No other advantages were found (secondary outcomes) and the interest of ICG appears to be limited for patients undergoing surgery for ALC.

Source: Current Problems in Surgery

DOI: 10.1016/j.cpsurg.2025.101788