RFA for Treatment of Intermediate Stage HCC

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Device: percutaneous radiofrequency ablation (RFA)

• Registration Number: NCT05281783
• Lead Sponsor: Benha University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-15
• Last Update Submitted: 2022-03-15
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Percutaneous Radiofrequency Ablation	percutaneous radiofrequency ablation (RFA)	We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).

Primary Outcome Measures

Name	Time	Method
The efficacy	six weeks after the date of the last ablation	By evaluating the HCC biomarkers as serum AFP and VEGF

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety]	six weeks after the date of the last ablation	By accounting for the number of adverse events

Trial Locations

Locations (1)

Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals; 🇪🇬 Banī Suwayf, Egypt