Comparative Evaluation of Standard Cholangiography, Intravenous, and Intracholecystic Indocyanine Green Fluorescence Cholangiography During Elective Laparoscopic Cholecystectomy: Results of a Three-Arm Randomized Trial

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Background and Objectives: Bile duct injury is a relatively rare, but critical complication of laparoscopic cholecystectomy and is most commonly attributed to misinterpretation of biliary anatomy. Intraoperative biliary imaging may enhance anatomical recognition and reduce operative uncertainty, yet the optimal imaging modality remains debated. This study aimed to compare conventional intraoperative X-ray cholangiography with two fluorescence-based techniques-intravenous and intracholecystic indocyanine green fluorescence cholangiography-with respect to biliary visualization, perioperative outcomes, and surgeon satisfaction during elective laparoscopic cholecystectomy. Materials and Methods: This prospective, single-center, single-blind randomized controlled trial included 240 adult patients scheduled for elective laparoscopic cholecystectomy between June 2021 and December 2022. Participants were randomized equally to standard intraoperative cholangiography, intravenous indocyanine green fluorescence cholangiography, or intracholecystic indocyanine green fluorescence cholangiography. The primary outcome was successful visualization of predefined extrahepatic biliary landmarks, including the critical junction. Secondary outcomes included cholangiography duration, perioperative complications, postoperative inflammatory markers, and surgeon satisfaction assessed using a five-point Likert scale. This study was registered at ClinicalTrials.gov (NCT04908826). Results: Visualization rates of the critical junction and major extrahepatic bile ducts were comparable among three groups, with no statistically significant differences observed. Both fluorescence-based techniques achieved a 100% technical success rate, whereas standard cholangiography failed in a small proportion of cases. Cholangiography duration was significantly shorter in the fluorescence groups compared with standard cholangiography (p < 0.001). Surgeon satisfaction scores were significantly higher for both fluorescence approaches, with a slight preference for intravenous administration. Perioperative complication rates and postoperative inflammatory markers were com-parable among groups. Conclusions: Intravenous and intracholecystic indocyanine green fluorescence cholangiography are non-inferior to conventional intraoperative cholangiography for biliary anatomy visualization and offer advantages in procedural efficiency and surgeon satisfaction. Fluorescence-based imaging represents a safe and effective alternative for intraoperative biliary mapping during elective laparoscopic cholecystectomy.

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