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

Zhujiang Hospital348 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

348

Conditions

Liver Cancer

Interventions

Indocyanine green for injectionDRUG

ICG will be injected to participants preoperatively for molecular fluorescence image

Eligibility

Sex: ALLMin age: 18 YearsMax age: 66 Years

Medical Language ↔ Plain English

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.

Locations (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

3-year disease free survival rate

No tumor recurrence within 3 years after surgery divided by total number of patients

Time frame: 36 months

Secondary Outcomes

Positive margin rate

Compare positive margin rate in both groups

Time frame: 14 days

Negative margin rate

Compare negative margin rate in both groups

Time frame: 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

Time frame: 14 days

Operation time

Compare operation time in both groups

Time frame: 1 day

Intraoperative blood loss

Compare intraoperative blood loss in both groups

Time frame: 1 day

Intraoperative blood transfusion volume

Compare intraoperative blood transfusion volume in both groups

Time frame: 1 day

The number of small lesions of HCC

Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group

Time frame: 14 days

Residual tumor at the margin of liver cross-section

Central Contacts

Chihua Fang, MD

CONTACT

13609700805 fangchihua@smu.edu.cn

Xiaojun Zeng

CONTACT

15626104890 zengxiaojun95@126.com

Data from ClinicalTrials.gov

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