Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: Indocyanine green for injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG molecular fluorescence imaging guided surgery<br>ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group | Drug: Indocyanine green for injection<br>* ICG will be injected to participants preoperatively for molecular fluorescence image<br>* Other names: ICG;|
| Placebo Comparator: No ICG molecular fluorescence imaging guided surgery<br>ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group | Drug: Indocyanine green for injection<br>* ICG will be injected to participants preoperatively for molecular fluorescence image<br>* Other names: ICG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year disease free survival rate | No tumor recurrence within 3 years after surgery divided by total number of patients | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive margin rate | Compare positive margin rate in both groups | 14 days | 
| Negative margin rate | Compare negative margin rate in both groups | 14 days | 
| Length of the shortest cutting edge | The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis | 14 days | 
| Operation time | Compare operation time in both groups | 1 day | 
| Intraoperative blood loss | Compare intraoperative blood loss in both groups | 1 day | 
| Intraoperative blood transfusion volume | Compare intraoperative blood transfusion volume in both groups | 1 day | 
| The number of small lesions of HCC | Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group | 14 days | 
| Residual tumor at the margin of liver cross-section | The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group | 14 days | 
| Intraoperative biliary fistula detection rate | 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. | 1 day | 
| Extrahepatic metastases of primary hepatocellular carcinoma | The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group | 14 days | 
| Postoperative hospital stay | 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. | 30 days | 
| Postoperative liver function index 1 | Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Postoperative liver function index 2 | Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Postoperative liver function index 3 | Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Postoperative liver function index 4 | Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Postoperative hemoglobin | Compare hemoglobin on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Postoperative platelets | Compare platelets on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Prothrombin time | Compare prothrombin time on postoperative days 1, 3, and 5 in both groups | 5 days | 
| Mortality rates | Perioperative death was defined as death occurring within 90 days after surgery | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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indocyanine green, local resection