RFA for Treatment of Intermediate Stage HCC

NCT05281783 | Completed

• 1 other identifier: FMBSUREC/10102021/Eid
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Percutaneous Radiofrequency Ablation; Intermediate Stage; Hepatocellular Carcinoma; Clinical Trial

Outcome Measures

Primary Outcomes (1)

• The efficacy

  By evaluating the HCC biomarkers as serum AFP and VEGF

  six weeks after the date of the last ablation

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety]

  six weeks after the date of the last ablation

Study Arms (1)

Percutaneous Radiofrequency Ablation

EXPERIMENTAL

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

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).

Percutaneous Radiofrequency Ablation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Benha University: lead
• Beni-Suef University: collaborator

Study Sites (1)

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

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Ragaey A Eid

  ragaeyahmad@med.bsu.edu.eg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single-center, prospective non-randomized, controlled clinical trial

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: October 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

EG (1)