Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
- Registration Number
- NCT05160740
- Lead Sponsor
- Zhujiang Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 348
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ICG molecular fluorescence imaging guided surgery Indocyanine green for injection ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group No ICG molecular fluorescence imaging guided surgery Indocyanine green for injection ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group
- Primary Outcome Measures
Name Time Method 3-year disease free survival rate 36 months No tumor recurrence within 3 years after surgery divided by total number of patients
- Secondary Outcome Measures
Name Time Method Intraoperative blood transfusion volume 1 day Compare intraoperative blood transfusion volume in both groups
The number of small lesions of HCC 14 days Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group
Residual tumor at the margin of liver cross-section 14 days The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group
Postoperative hospital stay 30 days Compare Postoperative hospital stay in both groups. Eg: Postoperative hospital stay is the number of days from the day of surgery to the day of discharge.
Length of the shortest cutting edge 14 days The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis
Positive margin rate 14 days Compare positive margin rate in both groups
Negative margin rate 14 days Compare negative margin rate in both groups
Operation time 1 day Compare operation time in both groups
Intraoperative blood loss 1 day Compare intraoperative blood loss in both groups
Intraoperative biliary fistula detection rate 1 day The number of cases of successful intraoperative detection of biliary fistula by fluorescence in the intervention group divided by the total number of cases in the intervention group.
Extrahepatic metastases of primary hepatocellular carcinoma 14 days The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group
Postoperative liver function index 1 5 days Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 4 5 days Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups
Prothrombin time 5 days Compare prothrombin time on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 2 5 days Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 3 5 days Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups
Postoperative hemoglobin 5 days Compare hemoglobin on postoperative days 1, 3, and 5 in both groups
Postoperative platelets 5 days Compare platelets on postoperative days 1, 3, and 5 in both groups
Mortality rates 3 months Perioperative death was defined as death occurring within 90 days after surgery
Trial Locations
- Locations (1)
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China