NCT07295275

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Mar 2026

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Mar 2026Sep 2028

First Submitted

Initial submission to the registry

December 7, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 3, 2026

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

December 7, 2025

Last Update Submit

March 1, 2026

Conditions

Liver Cancer

Keywords

Laparoscopic Anatomical Liver ResectionIndocyanine Green FluorescenceHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Overall Survival (OS)

    Up to 3 years post-surgery

  • Incidence of Perioperative Complications

    From surgery up to 90 days post-surgery

Other Outcomes (1)

  • Liver Function Recovery

    Pre-operative, Post-operative Days 1, 3, 5, and 1 month

Study Arms (2)

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)

Transportal ICG Group

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

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).

Transarterial ICG Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Central Study Contacts

Jiwei Huang Professor

CONTACT

18980606725huangjiwei@wchscu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 7, 2025

First Posted

December 19, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 3, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)