Clinical trial NCT05160740: Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
Official title: Multicenter Randomized Controlled Clinical Trial of Indocyanine Green Molecular Fluorescence Imaging in the Diagnosis and Treatment of Primary Liver Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Cancer
Keywords: indocyanine green
local resection
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 348
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 3-year disease free survival rate
timeFrame: 36 months
Secondary outcomes:
measure: Positive margin rate
timeFrame: 14 days
measure: Negative margin rate
timeFrame: 14 days
measure: Length of the shortest cutting edge
timeFrame: 14 days
measure: Operation time
timeFrame: 1 day
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Intraoperative blood transfusion volume
timeFrame: 1 day
measure: The number of small lesions of HCC
timeFrame: 14 days
measure: Residual tumor at the margin of liver cross-section
timeFrame: 14 days
measure: Intraoperative biliary fistula detection rate
timeFrame: 1 day
measure: Extrahepatic metastases of primary hepatocellular carcinoma
timeFrame: 14 days
measure: Postoperative hospital stay
timeFrame: 30 days
measure: Postoperative liver function index 1
timeFrame: 5 days
measure: Postoperative liver function index 2
timeFrame: 5 days
measure: Postoperative liver function index 3
timeFrame: 5 days
measure: Postoperative liver function index 4
timeFrame: 5 days
measure: Postoperative hemoglobin
timeFrame: 5 days
measure: Postoperative platelets
timeFrame: 5 days
measure: Prothrombin time
timeFrame: 5 days
measure: Mortality rates
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Chihua Fang, MD
role: STUDY_CHAIR
References: