Clinical Research Directory

Acute Cholecystitis Biliary Complications - ICG

Sponsor: Hospital del Mar

Summary

Acute cholecystitis is a common indication for emergency laparoscopic cholecystectomy. Inflammatory changes and distorted anatomy may increase the risk of biliary complications, including bile duct injury and bile leak, which are associated with significant morbidity, reinterventions, and prolonged hospitalization. Indocyanine green (ICG) fluorescence cholangiography allows real-time visualization of the extrahepatic biliary anatomy using near-infrared imaging and has shown to improve anatomical identification during elective cholecystectomy. However, its clinical impact in the emergency setting of acute cholecystitis has not been adequately evaluated in randomized multicenter trials. The objective of this study is to determine whether the use of ICG fluorescence cholangiography during emergency laparoscopic cholecystectomy reduces the incidence of clinically relevant biliary complications compared with standard surgery without ICG. This is a pragmatic, multicenter, open-label randomized controlled trial including 296 adult patients with acute cholecystitis undergoing urgent laparoscopic cholecystectomy. Participants will be randomized 1:1 to surgery with or without ICG fluorescence guidance. The primary outcome is the incidence of clinically relevant biliary complications, including bile duct injury or bile leak, within 90 days after surgery.

Official title: Multicenter Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence to Reduce Biliary Complications in Emergency Cholecystectomy for Acute Cholecystitis

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