RecruitingNCT07295275

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


Sponsor

West China Hospital

Enrollment

200 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria8

  • 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 Criteria8

  • 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.

Interventions

PROCEDURELaparoscopic 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).


Locations(3)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

West China Hospital

Chengdu, Sichuan, China

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NCT07295275


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