Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- West China Hospital
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Recurrence-Free Survival (RFS)
Overview
Brief 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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-80 years.
- •Postoperative histopathological diagnosis of Hepatocellular Carcinoma (HCC).
- •Underwent ICG fluorescence-guided laparoscopic anatomical liver resection.
- •Child-Pugh Class A or B.
- •ASA score I-III.
- •ECOG Performance Status 0-
- •No invasion of major vessels (main portal vein/first-order branches, main hepatic vein).
- •No distant metastasis.
Exclusion Criteria
- •Pathology confirms non-HCC components (e.g., cholangiocarcinoma, combined HCC-ICC) or metastatic liver cancer.
- •Concomitant other active malignancies.
- •Preoperative anti-tumor therapy (TACE, ablation, radiotherapy, systemic therapy) or history of prior hepatectomy.
- •Ruptured tumor.
- •Conversion to open surgery.
- •Unclear surgical records regarding ICG staining method.
- •Intraoperative ICG staining failure (e.g., diffuse staining, unclear boundaries) preventing fluorescence-guided resection.
- •Missing data preventing primary endpoint assessment.
Arms & Interventions
Transarterial ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.
Intervention: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG) (Procedure)
Transportal ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.
Outcomes
Primary Outcomes
Recurrence-Free Survival (RFS)
Time Frame: Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)
RFS is defined as the time interval from the date of surgery to the date of first documented tumor recurrence (intrahepatic or extrahepatic) or death from any cause. Evaluated using Kaplan-Meier analysis.
Secondary Outcomes
- Overall Survival (OS)(Up to 3 years post-surgery)
- Incidence of Perioperative Complications(From surgery up to 90 days post-surgery)
Investigators
Jiwei Huang
Clinical Professor
West China Hospital