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Completed

NCT Number: NCT05281783

RFA for Treatment of Intermediate Stage HCC

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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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

percutaneous radiofrequency ablation (RFA)

Device

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

Primary outcomes

  1. The efficacy

    Time frame: six weeks after the date of the last ablation

    By evaluating the HCC biomarkers as serum AFP and VEGF

Secondary outcomes

  1. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: six weeks after the date of the last ablation

    By accounting for the number of adverse events

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Beni-Suef University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 16, 2022
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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