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CompletedNCT05281783Updated Mar 16, 2022

RFA for Treatment of Intermediate Stage HCC

An interventional study of percutaneous radiofrequency ablation (RFA) in Hepatocellular Carcinoma, sponsored by Benha University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2022-03-16.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Oct 2018, registered Mar 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Percutaneous Radiofrequency Ablation
  • Intermediate Stage
  • Hepatocellular Carcinoma
  • Clinical Trial
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 120 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Percutaneous Radiofrequency Ablation

    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)

Interventions

  • Devicepercutaneous radiofrequency ablation (RFA)

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

06

What researchers measure

Primary outcomes

  1. The efficacy

    By evaluating the HCC biomarkers as serum AFP and VEGF

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

Secondary outcomes

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

    By accounting for the number of adverse events

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

07

Study locations

1 site
  • Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals
    Banī Suwayf, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05281783
Lead sponsor
Benha University
Collaborators
Beni-Suef University
Responsible party
Manar Ahmed Kamal (Principal Investigator, Benha University) — Principal investigator
First posted
Mar 16, 2022
Start date
Oct 1, 2018
Primary completion
Jun 1, 2021
Completion
Aug 1, 2021
Last update
Mar 16, 2022

Study contacts

Ragaey A Eid
principal investigator · ragaeyahmad@med.bsu.edu.eg

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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