Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Indocyanine green for injection
- Conditions
- Liver Cancer
- Sponsor
- Zhujiang Hospital
- Enrollment
- 348
- Locations
- 1
- Primary Endpoint
- 3-year disease free survival rate
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The of this study is to explore the clinical outcomes of indocyanine green molecular fluorescence imaging in local resection of primary hepatocellular carcinoma (CNLC Ⅰa stage).
Detailed Description
Indocyanine green molecular imaging technique is often used in the surgical treatment of primary liver cancer. Its application in hepatectomy of primary liver cancer is currently in the stage of case accumulation and clinical research. No prospective study has been conducted to determine the clinical efficacy of indocyanine green molecular imaging for local hepatectomy of primary liver cancer. On the basis of more than 1000 liver resection procedures, the investigators want to apply indocyanine green molecular imaging technology, a cheap, simple and radiation-free method, to guide surgical resection. The purpose is to assist surgical procedures and improve participants' tumor-free survival.
Investigators
Chihua Fang,MD
Clinical Professor
Zhujiang Hospital
Eligibility Criteria
Inclusion Criteria
- •First clinical diagnosis of primary liver cancer (China liver cancer staging, CNLC Ia stage);
- •Child-Pugh grading standard of liver function was GRADE A or B;
- •18-66 years old;
- •Complete clinical case data;
- •limited surgical methods (local resection);
- •Voluntarily participate in the study and sign the informed consent.
Exclusion Criteria
- •There are basic diseases that cannot tolerate surgery (such as severe cardiopulmonary cerebral renal insufficiency);
- •Tumor thrombus or distant metastasis was found in main portal vein and primary branch, main hepatic vein and branch, main hepatic vein and inferior vena cava by preoperative imaging examination;
- •planned pregnancy, unplanned pregnancy and pregnancy;
- •Preoperative child-Pugh grading standard of liver function was Grade C.
- •Disease researchers that the investigator considers inappropriate to participate in this clinical trial.
Arms & Interventions
ICG molecular fluorescence imaging guided surgery
ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group
Intervention: Indocyanine green for injection
No ICG molecular fluorescence imaging guided surgery
ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group
Intervention: Indocyanine green for injection
Outcomes
Primary Outcomes
3-year disease free survival rate
Time Frame: 36 months
No tumor recurrence within 3 years after surgery divided by total number of patients
Secondary Outcomes
- Intraoperative blood transfusion volume(1 day)
- The number of small lesions of HCC(14 days)
- Residual tumor at the margin of liver cross-section(14 days)
- Postoperative hospital stay(30 days)
- Length of the shortest cutting edge(14 days)
- Positive margin rate(14 days)
- Negative margin rate(14 days)
- Operation time(1 day)
- Intraoperative blood loss(1 day)
- Intraoperative biliary fistula detection rate(1 day)
- Extrahepatic metastases of primary hepatocellular carcinoma(14 days)
- Postoperative liver function index 1(5 days)
- Postoperative liver function index 4(5 days)
- Prothrombin time(5 days)
- Postoperative liver function index 2(5 days)
- Postoperative liver function index 3(5 days)
- Postoperative hemoglobin(5 days)
- Postoperative platelets(5 days)
- Mortality rates(3 months)