Comparing the Incidence of Bile Duct Injuries in Laparoscopic Cholecystectomy with and without use of Indocyanin green fluorescence dye (ICG) - A Randomized controlled trial

After obtaining approval from the Institutional Research Committee and Institutional Humuan Ethics Committee, patients planned for laparoscopic cholecystectomy who fulfill the inclusion and exclusion criteria will be enrolled in the study after taking written informed consent. The nature, purpose, benefits and possible risks of the study will be explained to all participants. Participation will be voluntary and patients may withdraw at any time without affecting their treatment.

A total of 60 patients with symptomatic gallstone disease will be included and randomly allocated into two groups using  group allocation concealment method. In Group A, laparoscopic cholecystectomy will be performed with the use of Indocyanine Green fluorescence dye for enhanced visualization of biliary anatomy. In Group B, standard laparoscopic cholecystectomy will be performed without the use of Indocyanine Green fluorescence guidance. The operating surgeon will assess the biliary anatomy and proceed as per standard surgical protocol.

The primary objective of the study is to compare the incidence of bile duct injuries between the two groups. Secondary outcomes include clear identification of the critical view of safety, operative time, conversion to open cholecystectomy, intraoperative and postoperative complications, length of postoperative hospital stay and the need for any re-intervention. Postoperative follow-up will be done at the time of discharge, at 1 month and at 3 months to assess recovery and detect any complications. The estimated duration of the study is 18 months.