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NCT Number: NCT07295275

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

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tsinghua Changgung Hospital, Beijing, Beijing Municipality, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 0-2.
  • 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.

Treatment and study plan

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).

Primary outcomes

  1. 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

  1. Overall Survival (OS)

    Time frame: Up to 3 years post-surgery

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

  2. Incidence of Perioperative Complications

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

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

Other outcomes

  1. Liver Function Recovery

    Time frame: Pre-operative, Post-operative Days 1, 3, 5, and 1 month

    Assessment of dynamic changes in liver function indicators, including Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBIL) levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiwei Huang Professor

CONTACT

[email protected]

18980606725

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 19, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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