Pilot Study on the Usefulness of Endoscopic Ultrasound-guided Biliary Drainage With a Newly Designed Hybrid Metallic Stent
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- The stent patency rate
研究概览
简要总结
The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.
详细描述
Endoscopic ultrasound-guided biliary drainage with a fully covered metallic stent was a safe and effective method in patients with malignant biliary obstructions and had a comparatively long patency duration. Nevertheless, the significant rate of distal stent migration cannot be ignored, suggesting the need for a newly designed metallic stent for endoscopic ultrasound-guided biliary drainage.
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
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20 years
- •The presence of an unresectable malignant biliary obstruction
- •Failed conventional ERCP stenting
排除标准
- •Age < 20 years
- •An inability to sedate the patient due to advanced heart or pulmonary diseases
- •A lack of informed consent
研究组 & 干预措施
hybrid metallic stent
Patients group who were inserted a hybrid metallic stent
干预措施: EUS-guided biliary drainage with a hybrid metallic stent (Device)
结局指标
主要结局
The stent patency rate
时间窗: Up to 48 weeks
次要结局
- Patients' survival rate(Up to 48 weeks)
- Complication rate related to the hybrid stents(Up to 48 weeks)
研究者
Tea Jun Song
Assistant professor
Inje University