Back to resultsIndocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer (ICGMFITinPLC)
Primary Purpose
Liver Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Indocyanine green for injection
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring indocyanine green, local resection
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.
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ICG molecular fluorescence imaging guided surgery
No ICG molecular fluorescence imaging guided surgery
Arm Description
ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group
ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group
Outcomes
Primary Outcome Measures
3-year disease free survival rate
No tumor recurrence within 3 years after surgery divided by total number of patients
Secondary Outcome Measures
Positive margin rate
Compare positive margin rate in both groups
Negative margin rate
Compare negative margin rate in both groups
Length of the shortest cutting edge
The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis
Operation time
Compare operation time in both groups
Intraoperative blood loss
Compare intraoperative blood loss in both groups
Intraoperative blood transfusion volume
Compare intraoperative blood transfusion volume in both groups
The number of small lesions of HCC
Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group
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
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.
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
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.
Postoperative liver function index 1
Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 2
Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 3
Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups
Postoperative liver function index 4
Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups
Postoperative hemoglobin
Compare hemoglobin on postoperative days 1, 3, and 5 in both groups
Postoperative platelets
Compare platelets on postoperative days 1, 3, and 5 in both groups
Prothrombin time
Compare prothrombin time on postoperative days 1, 3, and 5 in both groups
Mortality rates
Perioperative death was defined as death occurring within 90 days after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05160740
Brief Title
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
Acronym
ICGMFITinPLC
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
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 23, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
indocyanine green, local resection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
348 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICG molecular fluorescence imaging guided surgery
Arm Type
Experimental
Arm Description
ICG molecular fluorescence imaging will be used in local hepatectomy of primary liver cancer in this group
Arm Title
No ICG molecular fluorescence imaging guided surgery
Arm Type
Placebo Comparator
Arm Description
ICG molecular fluorescence imaging will not be used in local hepatectomy of primary liver cancer in this group
Intervention Type
Drug
Intervention Name(s)
Indocyanine green for injection
Other Intervention Name(s)
ICG
Intervention Description
ICG will be injected to participants preoperatively for molecular fluorescence image
Primary Outcome Measure Information:
Title
3-year disease free survival rate
Description
No tumor recurrence within 3 years after surgery divided by total number of patients
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Positive margin rate
Description
Compare positive margin rate in both groups
Time Frame
14 days
Title
Negative margin rate
Description
Compare negative margin rate in both groups
Time Frame
14 days
Title
Length of the shortest cutting edge
Description
The shortest distance between tumor and resection margin was compared between the two groups by pathological diagnosis
Time Frame
14 days
Title
Operation time
Description
Compare operation time in both groups
Time Frame
1 day
Title
Intraoperative blood loss
Description
Compare intraoperative blood loss in both groups
Time Frame
1 day
Title
Intraoperative blood transfusion volume
Description
Compare intraoperative blood transfusion volume in both groups
Time Frame
1 day
Title
The number of small lesions of HCC
Description
Small lesions detected by ICG fluorescence and confirmed by pathology in the intervention group
Time Frame
14 days
Title
Residual tumor at the margin of liver cross-section
Description
The number of residual tumors confirmed by ICG fluorescence detection at the liver margin of the intervention group
Time Frame
14 days
Title
Intraoperative biliary fistula detection rate
Description
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.
Time Frame
1 day
Title
Extrahepatic metastases of primary hepatocellular carcinoma
Description
The number of extrahepatic metastases of primary liver cancer detected by ICG and confirmed by pathology in the intervention group
Time Frame
14 days
Title
Postoperative hospital stay
Description
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.
Time Frame
30 days
Title
Postoperative liver function index 1
Description
Compare the levels of Alanine aminotransferase on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Postoperative liver function index 2
Description
Compare the levels of Aspartate aminotransferase on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Postoperative liver function index 3
Description
Compare the levels of serum albumin on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Postoperative liver function index 4
Description
Compare the levels of total bilirubin on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Postoperative hemoglobin
Description
Compare hemoglobin on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Postoperative platelets
Description
Compare platelets on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Prothrombin time
Description
Compare prothrombin time on postoperative days 1, 3, and 5 in both groups
Time Frame
5 days
Title
Mortality rates
Description
Perioperative death was defined as death occurring within 90 days after surgery
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chihua Fang, MD
Phone
13609700805
Email
fangchihua@smu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaojun Zeng
Phone
15626104890
Email
zengxiaojun95@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, MD
Organizational Affiliation
Zhujiang Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chihua Fang, M.D
Phone
(+86)2062782568
Email
fangch_dr@163.com
First Name & Middle Initial & Last Name & Degree
Xiaojun Zeng
Phone
(+86)2062782568
Email
zengxiaojun95@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
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