Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization
研究概览
简要总结
Transfemoral Versus Transradial Approach in Transarterial Chemoembolization of Hepatocellular Carcinoma
详细描述
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Hepatocellular carcinoma of BCLC (Barcelona Clinic Liver Cancer) stage B
- •Also for BCLC stage A patients, in whom ablative therapy has technical limitations.
- •Downsizing tumor for resection or transplantation.
排除标准
- •Factors related to liver cirrhosis:
- •Decompensated cirrhosis (Child-Pugh B and C, score >8), including jaundice, clinical hepatic encephalopathy, and refractory ascites and/ or hepatorenal syndrome
- •Impaired portal-vein blood flow (portal-vein thrombus, hepatofugal blood flow)
- •Factors related to HCC:
- •Extensive tumor involving the entirety of both lobes of the liver
- •Malignant portal vein thrombosis
- •Extra-hepatic metastases
- •Impaired renal function:
- •Creatinine ≥2 mg/dl or creatinine clearance <30 ml/min
- •Factors related to procedure (Radial artery access):
- •Existing AV (arteriovenous) fistula or graft
- •Pervious major surgery to forearm or wrist
- •Vasculitis
- •Pervious access failure
- •Skin infection or compromised integrity
- •Artery size <2mm
- •Intolerance of hyperextended wrist positioning
- •Severe vasospasm
- •Vessel tortuosity
- •Radial loops
- •Absent or occluded radial artery
- •Atherosclerotic or calcific PAD (peripheral artery disease)
- •Coagulopathy INR>1.5 platelets count <50.000/mmc
结局指标
主要结局
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization
时间窗: Baseline
To compare transfemoral approach (TFA) and transradial approach (TRA) in patients undergoing hepatic chemoembolization in terms of safety, feasibility, and procedural variables, including fluoroscopy time and patient preference.
次要结局
未报告次要终点
研究者
Ali Adel Abouelmagd Sewisy
M.B.B.CH at Radiology department of Assuit university
Assiut University