Transarterial ICG-guided laparoscopic anatomical liver resection for hepatocellular carcinoma
Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
This study tests whether using trans-arterial indocyanine green (ICG) dye to guide laparoscopic anatomical liver resection reduces cancer recurrence in people with hepatocellular carcinoma compared with the conventional portal-vein ICG method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | West China Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Trial ID | NCT07295275 on ClinicalTrials.gov |
What this trial studies
This multicenter ambispective cohort compares trans-arterial ICG fluorescence guidance versus conventional trans-portal ICG guidance for laparoscopic anatomical liver resection in patients with hepatocellular carcinoma. The retrospective arm collects cases from June 2020 to August 2025 and the prospective arm will enroll patients from January 2026 to January 2027 across three hospitals. The primary endpoint is recurrence-free survival, with secondary endpoints including perioperative safety, postoperative liver function recovery, and overall survival. Patients included are adults with histologically confirmed HCC who underwent ICG fluorescence-guided laparoscopic anatomical resection and meet liver function and performance-status criteria.
Who should consider this trial
Good fit: Ideal candidates are adults 18–80 years old with histologically confirmed hepatocellular carcinoma, Child-Pugh A or B liver function, ASA I–III, ECOG 0–2, no major vessel invasion or distant metastasis, and who undergo ICG fluorescence-guided laparoscopic anatomical liver resection.
Not a fit: Patients with non-HCC pathology, concurrent other active malignancies, prior anti-tumor therapy or prior hepatectomy, ruptured tumors, conversion to open surgery, intraoperative ICG staining failure, or missing key data are unlikely to benefit from inclusion.
Why it matters
Potential benefit: If successful, the trans-arterial ICG approach could reduce tumor recurrence after laparoscopic anatomical liver resection and improve long-term outcomes while maintaining perioperative safety.
How similar studies have performed: ICG fluorescence via portal staining has been used to map liver segments and aid resection, but the trans-arterial ICG navigation approach is newer and comparative evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Beijing, Beijing Municipality and 2 other locations
- Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Recruiting)
- West China Hospital — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Study coordinator: Jiwei Huang Professor
- Email: huangjiwei@wchscu.cn
- Phone: 18980606725
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.