Study Comparing a New ICG-Albumin Method With Standard ICG for Fluorescence-Guided Laparoscopic Liver Cancer Surgery

What this Trial Is About

Researchers are investigating a new method to improve imaging during laparoscopic anatomical liver resection in patients with primary liver cancer. This randomized, double-blinded trial compares a novel protocol that mixes indocyanine green ICG with human serum albumin HSA to the standard ICG protocol. The study aims to provide better evidence on how to optimize ICG use for clearer fluorescence imaging, which may help surgeons define liver segments and tumor margins more precisely during surgery. Participants will be randomly assigned to one of two groups. The experimental group receives an intravenous infusion of the ICG-albumin complex after ligation of the target hepatic portal vein, while the control group receives a standard bolus injection of ICG alone. The infusion in the experimental group is given slowly until sufficient fluorescence is observed. This study includes a screening period before surgery and follow-up visits scheduled up to 36 months post-surgery. During the study, patients will be monitored closely with assessments including a 5-point fluorescence imaging score by independent experts as the primary outcome. Secondary outcomes include operation time, blood loss, tumor margin status, complications, liver function recovery, and long-term recurrence and survival. Safety is monitored by reporting adverse reactions and complications. Data collection and analysis will help determine if the new protocol can improve surgical precision and outcomes. The total participation time includes screening, surgery, hospitalization, and long-term follow-up visits.

Application of ICG@HSA Complexes in Fluorescence Image-Guided Laparoscopic Anatomical Liver Resection