RFA for Treatment of Intermediate Stage HCC

Study Overview
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Brief Summary
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In Egypt, chronic hepatitis C virus (HCV) is the most prevalent cause of hepatoma. The study aims to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC). The present study was a single-center, prospective non-randomized, controlled clinical trial in the Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals, between October 2018 and August 2021. Abdominal ultrasonography and triphasic computerized tomography (CT) abdomen were used to diagnose HCC. The abdominal ultrasonography and a dynamic CT scan were performed six weeks following the ablation to assess treatment efficacy.

Official Title
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Efficacy and Response Predictors of Percutaneous Radiofrequency Ablation for Treatment of Intermediate Stage Hepatocellular Carcinoma: A Controlled Clinical Trial

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Device: percutaneous radiofrequency ablation (RFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were early and intermediate-stage HCC (BCLC stage A and B). Patients accepted to be treated by percutaneous radiofrequency ablation in the Interventional Ultrasonography Unit. Patients with early-stage-HCC should have up to 3 tumors, all smaller than 3 cm with a Child-Pugh A score. Patients with intermediate-stages-HCC should have multinodular HCC (>3 nodules <3 cm) or single focal lesion more than 3 cm, with Child-Pugh Score A or B liver cirrhosis, international normalized ratio (INR) less than 1.7, and platelet count more than 50,000/cm. Exclusion Criteria: Patients with HCC with and vascular spread (portal vein thrombosis), lymph node metastasis or distant metastasis, subcapsular lesions, or lesions with close vicinity to the gall bladder, bowel, or portal vein. Patients with clinically decompensated liver disease (Child-Pugh Score C liver cirrhosis).
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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single-center, prospective non-randomized, controlled clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Percutaneous Radiofrequency Ablation<br>We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC). | Device: percutaneous radiofrequency ablation (RFA)<br>* We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy | By evaluating the HCC biomarkers as serum AFP and VEGF | six weeks after the date of the last ablation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety] | By accounting for the number of adverse events | six weeks after the date of the last ablation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Radiofrequency Ablation, Intermediate Stage, Hepatocellular Carcinoma, Clinical Trial