RFA for Treatment of Intermediate Stage HCC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-08-01

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.

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Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single-center, prospective non-randomized, controlled clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous Radiofrequency Ablation

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

Group Type EXPERIMENTAL

percutaneous radiofrequency ablation (RFA)

Intervention Type DEVICE

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

Interventions

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percutaneous radiofrequency ablation (RFA)

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

Intervention Type DEVICE

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).

Eligible Sex

ALL

Accepts Healthy Volunteers

No