Efficacy and Response Predictors of Percutaneous Radiofrequency Ablation for Treatment of Intermediate Stage Hepatocellular Carcinoma: A Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The efficacy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Percutaneous Radiofrequency Ablation
We aim to evaluate the percutaneous radiofrequency ablation (RFA) efficacy as monotherapy in intermediate versus early-stage hepatocellular carcinoma (HCC).
干预措施: percutaneous radiofrequency ablation (RFA) (Device)
结局指标
主要结局
The efficacy
时间窗: six weeks after the date of the last ablation
By evaluating the HCC biomarkers as serum AFP and VEGF
次要结局
- Incidence of Treatment-Emergent Adverse Events [Safety](six weeks after the date of the last ablation)
研究者
Manar Ahmed Kamal
Principal Investigator
Benha University