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

Sichuan University

Status: Enrolling

Conditions: Liver Cancer

Treatments: Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)

Study type: Observational

Funder types: Other

Identifiers

NCT07295275

JHuang20235

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18-80 years.
2. Postoperative histopathological diagnosis of Hepatocellular Carcinoma (HCC).
3. Underwent ICG fluorescence-guided laparoscopic anatomical liver resection.
4. Child-Pugh Class A or B.
5. ASA score I-III.
6. ECOG Performance Status 0-2.
7. No invasion of major vessels (main portal vein/first-order branches, main hepatic vein).
8. No distant metastasis.

Exclusion criteria

1. Pathology confirms non-HCC components (e.g., cholangiocarcinoma, combined HCC-ICC) or metastatic liver cancer.
2. Concomitant other active malignancies.
3. Preoperative anti-tumor therapy (TACE, ablation, radiotherapy, systemic therapy) or history of prior hepatectomy.
4. Ruptured tumor.
5. Conversion to open surgery.
6. Unclear surgical records regarding ICG staining method.
7. Intraoperative ICG staining failure (e.g., diffuse staining, unclear boundaries) preventing fluorescence-guided resection.
8. Missing data preventing primary endpoint assessment.

Trial design

200 participants in 2 patient groups

Transarterial ICG Group

Description:

Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.

Treatment:

Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)

Transportal ICG Group

Description:

Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.