RFA for Treatment of Intermediate Stage HCC

Benha University

Status: Completed

Conditions: Hepatocellular Carcinoma

Treatments: Device: percutaneous radiofrequency ablation (RFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05281783

FMBSUREC/10102021/Eid

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Percutaneous Radiofrequency Ablation

Experimental group

Description:

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

Treatment:

Device: percutaneous radiofrequency ablation (RFA)