The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma

Study Overview
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Brief Summary
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This study aims to evaluate the feasibility of indocyanine green (ICG)-based fluorescence imaging in the detection of liver tumors. By correlating the ICG fluorescence patterns with pathologically confirmed tumors , it would be possible to use fluorescence navigation system in helping promoting oncology treatment.

Official Title
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The Application of Indocyanine-Green(ICG) Fluorescence Imaging in Hepatocellular Carcinoma

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Indocyanine-Green(ICG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years≤ Age ≤70 years Compling with the diagnosis criteria of hepatic carcinoma. Primary hepatic carcinoma without intrahepatic or extrahepatic extensive cancer metastasis, the metastatic hepatic carcinoma whose primary focal has been controlled. Preoperative liver function is Child - Pugh grade A or B. The patients are volunteered for the study. Exclusion Criteria: Patients with mental illness. Patients can't tolerate the operation owe to a variety of basic diseases (such as severe cardiopulmonary insufficiency, renal insufficiency, cachexia and blood system diseases, etc. The patients refused to take part in the study. There are other co-existed malignant tumors. Benign liver diseases. Indocyanine green allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indocyanine-Green(ICG) injection group<br> | Drug: Indocyanine-Green(ICG)<br>* ICG was administered intravenously 24 hours before the operation , or directly into the portal vein branches supplying the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of detecting small liver tumor by ICG fluorescence. | The tumor which aggregate ICG fluorescence will be resected and dignosed by pathology. The accuracy of detecting small liver tumor by ICG fluorescence will be evaluated. | 3 Days | 
| The accuracy of positive margins of resection detected by ICG fluorescence. | The surgery margins will be detected by ICG fluorescence. If there is fluorescence aggregating, we consider the presence of residual tumor in the margin and proven by histological examination. | 3 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, Indocyanine-Green(ICG)