Hepatocellular Carcinoma
Conditions
Keywords
Percutaneous Radiofrequency Ablation, Intermediate Stage, Hepatocellular Carcinoma, Clinical Trial
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.
Interventions
We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).
Sponsors
Beni-Suef University
Benha University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, prospective non-randomized, controlled clinical trial
Eligibility
Sex/Gender
ALL
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
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The efficacy | six weeks after the date of the last ablation | By evaluating the HCC biomarkers as serum AFP and VEGF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety] | six weeks after the date of the last ablation | By accounting for the number of adverse events |
Countries
Egypt
Outcome results
None listed