Quality of Life in Patients With Unresectable Hilar Cholangiocarcinoma on Palliative Metallic Stent Versus Plastic Stent: A Randomized Control Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
研究概览
简要总结
The purpose of this study is to compare the quality of life in patients with unresectable hilar cholangiocarcinoma on palliative metallic stent versus plastic Stent.
详细描述
In the patient with unresectable hilar cholangiocarcinoma,palliative biliary stent is the one way to help him.
The aim of palliative treatment is to improve quality of life and relief symptom,or sometime ,extended survival rate.
There are two types of biliary stent:
- plastic stent made from polyethylene or polytetrafluoroethylene
- metalic stent braided in the form of a tubular mesh from surgical-grade stainless steel alloy and designed to expand to a maximum diameter of 10mm.
The main drawback of plastic stent is relatively high occlusion rate, but its advantage is the lower cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patient with diagnosis of hilar cholangiocarcinoma and/or radiological diagnosis
- •Patient considered having an unresectable tumor or unfit of operation because of advanced age or medical illness
排除标准
- •Patient with ASA 4 or 5
- •Patient who inability to comply with follow up
- •Patient refused to join the research
研究组 & 干预措施
1
metallic stent group
干预措施: biliary stent (Device)
2
plastic stent group
干预措施: biliary stent (Device)
结局指标
主要结局
To assessment of the quality of life of patient with unresectable hilar cholangiocarcinoma after palliative biliary stent.
时间窗: 2-4 weeks
次要结局
- To assessment of early and late complication after palliative stent.(After stent insertion for sixth month and one year or until patients were expired)
- Survival rate at sixth month and one year.(After stent insertion for sixth month and one year or until patients were expired)