Comparing Two Doses of Indocyanine Green for Fluorescence Imaging During Laparoscopic Gallbladder Surgery

What this Trial Is About

Researchers are evaluating the use of two different doses of indocyanine green ICG in near-infrared fluorescent cholangiography during laparoscopic cholecystectomy LC, a common surgery to treat symptomatic gallstones. This phase IV randomized trial aims to compare the effectiveness of a standard 2.5 mg dose given over 3 hours before surgery with a reduced 0.25 mg dose given 15 to 30 minutes prior. The goal is to improve visualization of bile ducts and reduce complications like bile duct injury. Participants will be randomly assigned to one of two groups receiving ICG intravenously either 2.5 mg at least 3 hours before surgery or 0.25 mg 15 to 30 minutes before surgery. During surgery, surgeons will assess how well the bile ducts and liver structures can be seen using fluorescence. The study also considers factors like body mass index, type of biliary disease, surgery difficulty, and imaging system used. Fluorescence will be measured both by the surgical teams observations and with digital analysis software. Throughout the study, participants will undergo laparoscopic cholecystectomy with ICG fluorescence cholangiography monitored during surgery. Researchers will measure identification rates of biliary structures before and after dissection, the helpfulness of fluorescence imaging, liver background fluorescence interference, and correlate subjective observations with objective imaging data. The study follows participants for 30 days after surgery to track complications, mortality, operative time, and hospital stay. The total study duration is 13 months, including recruitment and follow-up.

Comparison Between Standard and Reduced Doses of Indocyanine Green in Fluorescence Cholangiography During Laparoscopic Cholecystectomy.