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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Procedure: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG)

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Beijing Tsinghua Changgung Hospital
      • Contact: Lei Yang Professor; Phone Number: 18810127955
  • Jiangsu
    • Xuzhou, Jiangsu, China
      • Recruiting
      • Xuzhou Central Hospital
      • Contact: Lin Zhang Professor; Phone Number: 17683009870
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital
      • Contact: Jiwei Huang Professor; Phone Number: 18980606725; Email: huangjiwei@wchscu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 to 80 years with a histopathological diagnosis of Hepatocellular Carcinoma (HCC). The population consists of patients who have undergone (retrospective cohort) or are scheduled to undergo (prospective cohort) laparoscopic anatomical liver resection guided by Indocyanine Green (ICG) fluorescence imaging at one of the participating centers. Participants must have Child-Pugh class A or B liver function and no evidence of major vascular invasion or distant metastasis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Transarterial ICG Group; Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.	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).
Transportal ICG Group; Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 18 months post-surgery (assessing the 18-month RFS rate as a key benchmark)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from the date of surgery to the date of death from any cause.	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.	From surgery up to 90 days post-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Function Recovery	Assessment of dynamic changes in liver function indicators, including Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBIL) levels.	Pre-operative, Post-operative Days 1, 3, 5, and 1 month

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 1, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Indocyanine Green Fluorescence; Laparoscopic Anatomical Liver Resection
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: JHuang20235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No