Liver Cancer
Conditions
Keywords
Laparoscopic Anatomical Liver Resection, Indocyanine Green Fluorescence, Hepatocellular Carcinoma
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.
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).
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).
Sponsors
West China Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-Free Survival (RFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Incidence of Perioperative Complications | 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. |
Countries
China
Contacts
CONTACTJiwei Huang Professor
Outcome results
None listed