RFA for Treatment of Intermediate Stage HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05281783
• Other study ID #: FMBSUREC/10102021/Eid
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Egypt	Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals	Bani Suwayf

Sponsors (2)

Lead Sponsor	Collaborator
Benha University	Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy	By evaluating the HCC biomarkers as serum AFP and VEGF	six weeks after the date of the last ablation
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety]	By accounting for the number of adverse events	six weeks after the date of the last ablation