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

Liver Cancer Clinical Trial

— ICGMFITinPLC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160740
• Other study ID #: 2021-KY-090-01
• Status: Recruiting
• Phase: N/A
• Start date: September 23, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2022
• Source: Zhujiang Hospital
• Contact: Chihua Fang, MD
• Phone: 13609700805
• Email: fangchihua[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 66 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• Indocyanine green for injection
ICG will be injected to participants preoperatively for molecular fluorescence image

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate	No tumor recurrence within 3 years after surgery divided by total number of patients	36 months
Secondary	Positive margin rate	Compare positive margin rate in both groups	14 days
Secondary	Negative margin rate	Compare negative margin rate in both groups	14 days
Secondary	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
Secondary	Operation time	Compare operation time in both groups	1 day
Secondary	Intraoperative blood loss	Compare intraoperative blood loss in both groups	1 day
Secondary	Intraoperative blood transfusion volume	Compare intraoperative blood transfusion volume in both groups	1 day
Secondary	The number of small lesions of HCC	Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group	14 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative liver function index 1	Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Postoperative liver function index 2	Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Postoperative liver function index 3	Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Postoperative liver function index 4	Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Postoperative hemoglobin	Compare hemoglobin on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Postoperative platelets	Compare platelets on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Prothrombin time	Compare prothrombin time on postoperative days 1, 3, and 5 in both groups	5 days
Secondary	Mortality rates	Perioperative death was defined as death occurring within 90 days after surgery	3 months