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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transarterial ICG Group | Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG. |
| |
| Transportal ICG Group | Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of surgery to the date of death from any cause. | Up to 3 years post-surgery |
| Incidence of Perioperative Complications | Number of participants with postoperative complications (e.g., bile leakage, hemorrhage, infection, liver failure), graded according to the Clavien-Dindo classification system. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Recovery | Assessment of dynamic changes in liver function indicators, including Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Total Bilirubin (TBIL) levels. | Pre-operative, Post-operative Days 1, 3, 5, and 1 month |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiwei Huang Professor | Contact | 18980606725 | huangjiwei@wchscu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| From surgery up to 90 days post-surgery |
| Xuzhou Central Hospital | Recruiting | Xuzhou | Jiangsu | China |
|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |