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

West China Hospital200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Liver Cancer

Interventions

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

Laparoscopic liver resection using ICG fluorescence imaging for tumor and liver segment visualization. Comparison lies in the route of ICG administration (Arterial vs. Portal).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

RECRUITING

West China Hospital

Chengdu, Sichuan, China

RECRUITING

Outcomes

Primary Outcomes

Recurrence-Free Survival (RFS)

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.

Time frame: Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)

Secondary Outcomes

Overall Survival (OS)

OS is defined as the time from the date of surgery to the date of death from any cause.

Time frame: Up to 3 years post-surgery

Incidence of Perioperative Complications

Number of participants with postoperative complications (e.g., bile leakage, hemorrhage, infection, liver failure), graded according to the Clavien-Dindo classification system.

Time frame: From surgery up to 90 days post-surgery

Central Contacts

Jiwei Huang Professor

CONTACT

18980606725 huangjiwei@wchscu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.