ICG fluorescence imaging-guided bile leak detection to reduce clinically relevant bile leakage after hepatectomy: A protocol for a systematic review and meta-analysis

BACKGROUND: Bile leakage remains a clinically relevant complication after hepatectomy and contributes to morbidity, prolonged drainage, extended hospital stay, and the need for reintervention. Intraoperative indocyanine green (ICG) fluorescence imaging can be used to visualize bile leaks from the transection plane or biliary stump, enabling targeted repair. However, evidence for the effect of this technique on clinically relevant bile leakage is heterogeneous and has not been systematically synthesized. METHODS AND ANALYSIS: This protocol describes a systematic review and meta-analysis of randomised controlled trials and comparative nonrandomised studies evaluating indocyanine green fluorescence imaging-guided intraoperative bile leak detection during hepatectomy. MEDLINE, Embase, Cochrane CENTRAL, and the Web of Science Core Collection will be searched from inception, along with trial registries and citation tracking. The primary outcome is clinically relevant postoperative bile leakage, defined as International Study Group of Liver Surgery (ISGLS) grade B or C. Secondary outcomes include any bile leakage, bile leak-related interventions, major postoperative complications, length of postoperative hospital stay, and mortality. Randomised and nonrandomised studies will be synthesized separately. A meta-analysis will be performed when the studies are sufficiently comparable; otherwise, the findings will be summarized narratively. Planned analyses include random-effects models, subgroup analyses stratified according to the route of indocyanine green administration, sensitivity analyses, and an assessment of the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation approach. This protocol is registered in PROSPERO (CRD420261291065). This manuscript describes the planned methods only; study selection, data extraction, and evidence synthesis results will be reported in the completed systematic review. ETHICS AND DISSEMINATION: This study will use data from published studies and does not require ethics approval. The findings will be disseminated through peer-reviewed publications and conference presentations.