Safety and Efficacy of Trans-arterial Versus Trans-portal ICG Fluorescence-Guided Laparoscopic Liver Watershed Resection: A Multicenter, Ambispective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Recurrence-Free Survival (RFS)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •No invasion of major vessels (main portal vein/first-order branches, main hepatic vein).
- •No distant metastasis.
排除标准
- •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.
研究组 & 干预措施
Transarterial ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by superselective transarterial injection of ICG.
干预措施: Laparoscopic Anatomical Liver Resection (guided by transarterial injection of ICG) (Procedure)
Transportal ICG Group
Patients who underwent laparoscopic anatomical liver resection guided by transportal (portal vein) injection of ICG.
结局指标
主要结局
Recurrence-Free Survival (RFS)
时间窗: 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.
次要结局
- Overall Survival (OS)(Up to 3 years post-surgery)
- Incidence of Perioperative Complications(From surgery up to 90 days post-surgery)
研究者
Jiwei Huang
Clinical Professor
West China Hospital