Safety and Efficacy of Transarterial ICG Fluorescence-Guided Laparoscopic Anatomical Liver Resection
NCT ID: NCT07295275
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2026-01-01
2028-09-01
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Transarterial ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.
Laparoscopic 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).
Transportal ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.
No interventions assigned to this group
Interventions
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Laparoscopic 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).
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Jiwei Huang
Clinical Professor
Locations
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Lei Yang Professor
Role: primary
Lin Zhang Professor
Role: primary
Jiwei Huang Professor
Role: primary
Other Identifiers
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JHuang20235
Identifier Type: -
Identifier Source: org_study_id