Optimizing Indocyanine Green Fluorescence Cholangiography in Laparoscopic Cholecystectomy: A Systematic Review of Randomized Controlled Trials on Dose, Timing, Route, Efficacy, and Safety

Background and Objectives: Near-infrared fluorescence cholangiography with indocyanine green (ICG) has been proposed as an adjunct for improving biliary anatomy recognition during laparoscopic cholecystectomy. However, uncertainty remains regarding its comparative efficacy, operative value, safety, and optimal route, dose, and timing. Materials and Methods: A systematic review was conducted to identify randomized comparative and dose-finding studies evaluating ICG fluorescence cholangiography during laparoscopic cholecystectomy. Outcomes included visualization of the cystic duct, common hepatic duct, common bile duct, biliary junctions, operative time, time to critical anatomical identification, conversion or bailout procedures, length of stay, bile duct injury, bile leak, and ICG-related adverse events. Clinical and methodological heterogeneity precluded meta-analysis; findings were synthesized descriptively. Results: Eighteen studies were included. ICG improved visualization of selected biliary structures compared with white-light imaging, particularly before dissection, whereas differences versus radiographic intraoperative cholangiography were less pronounced. Operative effects were inconsistent: several studies reported shorter cholangiography duration or earlier anatomical identification, without consistent reductions in total operative time or length of stay. Bile duct injuries and bile leaks were infrequent, but event numbers were insufficient to establish a protective effect or comparative safety. Selected dose comparisons suggested reduced hepatic background fluorescence with lower doses, although findings depended on administration timing and imaging platform. Interpretation was limited by subjective visualization assessment, risk of bias, and heterogeneous patient populations. Conclusions: ICG fluorescence cholangiography improves visualization of selected biliary structures, but improved visualization should not be equated with demonstrated clinical benefit. Evidence remains insufficient to establish reductions in bile duct injury, conversion, or postoperative morbidity, or a universally optimal route, dose, or timing regimen.