Back to resultsRFA for Treatment of Intermediate Stage HCC
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
percutaneous radiofrequency ablation (RFA)
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Percutaneous Radiofrequency Ablation, Intermediate Stage, Hepatocellular Carcinoma, Clinical Trial
Eligibility Criteria
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).
Sites / Locations
- Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Percutaneous Radiofrequency Ablation
Arm Description
We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).
Outcomes
Primary Outcome Measures
The efficacy
By evaluating the HCC biomarkers as serum AFP and VEGF
Secondary Outcome Measures
Incidence of Treatment-Emergent Adverse Events [Safety]
By accounting for the number of adverse events
Full Information
NCT ID
NCT05281783
First Posted
March 7, 2022
Last Updated
March 15, 2022
Sponsor
Benha University
Collaborators
Beni-Suef University
1. Study Identification
Unique Protocol Identification Number
NCT05281783
Brief Title
RFA for Treatment of Intermediate Stage HCC
Official Title
Efficacy and Response Predictors of Percutaneous Radiofrequency Ablation for Treatment of Intermediate Stage Hepatocellular Carcinoma: A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
Beni-Suef University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Percutaneous Radiofrequency Ablation, Intermediate Stage, Hepatocellular Carcinoma, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single-center, prospective non-randomized, controlled clinical trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Percutaneous Radiofrequency Ablation
Arm Type
Experimental
Arm Description
We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).
Intervention Type
Device
Intervention Name(s)
percutaneous radiofrequency ablation (RFA)
Intervention Description
We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).
Primary Outcome Measure Information:
Title
The efficacy
Description
By evaluating the HCC biomarkers as serum AFP and VEGF
Time Frame
six weeks after the date of the last ablation
Secondary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events [Safety]
Description
By accounting for the number of adverse events
Time Frame
six weeks after the date of the last ablation
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragaey A Eid
Organizational Affiliation
ragaeyahmad@med.bsu.edu.eg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interventional Ultrasonography Unit, Tropical Medicine Department, Beni-Suef University Hospitals
City
Banī Suwayf
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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RFA for Treatment of Intermediate Stage HCC
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