NCT07295275

Safety and Efficacy of Transarterial ICG Fluorescence-Guided Laparoscopic Anatomical Liver Resection

Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, ambispective cohort study evaluates the safety and efficacy of trans-arterial Indocyanine Green (ICG) fluorescence-guided laparoscopic liver watershed resection for Hepatocellular Carcinoma (HCC). The study aims to compare the outcomes of the trans-arterial ICG staining approach versus the conventional trans-portal (portal vein) ICG staining approach.

Detailed description

The study employs an ambispective design, comprising: A Retrospective Cohort: Collecting clinical data from patients treated between June 2020 and August 2025. A Prospective Cohort: Enrolling new patients from January 2026 to January 2027. Data will be collected from three medical centers. The primary objective is to compare the oncological prognosis, specifically Recurrence-Free Survival (RFS), between the two navigation methods. Secondary objectives include perioperative safety, liver function recovery, and Overall Survival (OS).

Conditions

• Liver Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)	Laparoscopic liver resection using ICG fluorescence imaging for tumor and liver segment visualization. Comparison lies in the route of ICG administration (Arterial vs. Portal).

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-01-01
• Completion: 2028-09-01
• First posted: 2025-12-19
• Last updated: 2026-03-03

Locations

3 sites across 1 country: China