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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Drug: Indocyanine green for injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 348
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chihua Fang, MD; Phone Number: 13609700805; Email: fangchihua@smu.edu.cn
• Study Contact Backup: Name: Xiaojun Zeng; Phone Number: 15626104890; Email: zengxiaojun95@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Recruiting
      • Zhujiang Hospital of Southern Medical University
      • Contact: Chihua Fang, M.D; Phone Number: (+86)2062782568; Email: fangch_dr@163.com
      • Contact: Xiaojun Zeng; Phone Number: (+86)2062782568; Email: zengxiaojun95@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Investigators: Study Chair: Chihua Fang, MD, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 21, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: indocyanine green; local resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 2021-KY-090-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No