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

Zhujiang Hospital

Status: Enrolling

Conditions: Liver Cancer

Treatments: Drug: Indocyanine green for injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05160740

2021-KY-090-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 348 estimated patients

Sex: All

Ages: 18 to 66 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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348 participants in 2 patient groups, including a placebo group

ICG molecular fluorescence imaging guided surgery

Experimental group

Description:

ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group

Treatment:

Drug: Indocyanine green for injection

No ICG molecular fluorescence imaging guided surgery

Placebo Comparator group

Description:

ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group

Treatment:

Drug: Indocyanine green for injection