Biodegradable Stent Implantation in Biliary Benign Strictures. Spanish Register.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Biliary duct patency: bilirubin alterations (> 2.2)
研究概览
简要总结
Spanish registry of resorbable stent implantation in biliary benign strictures.
This registry is sponsored by the Spanish Society of Vascular and Interventional Radiology (SERVEI) and conducted by the Research Group GITMI (Group of Research in Minimally Invasive Techniques) of the University of Zaragoza (Spain).
A software tool hosted on the official website of SERVEI and the journal Intervencionismo will be used for data collection a(https://estudios.watsoncme.com).
详细描述
This is an prospective observational study of patients that have been implanted a biodegradable stent in the biliary tree.
Patients are recruited when the stent is implanted, and the investigators perfom a patients follow-up during 1, 3, 6, 12, 24, 36, 48 and 52 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Older than 18 years-old
- •Informed consent
- •Non-lithiasic chronic bening single or multiple stenosis
- •Possibility of follow-up plus 1 year
排除标准
- •Under 18 years old
- •Unsigned consent
- •Non treatable coagulopathy
- •Acute signs of infection
- •Diagnosis of neoplasia
结局指标
主要结局
Biliary duct patency: bilirubin alterations (> 2.2)
时间窗: 24 months
Biliary duct patency after stent implantation evaluating bilirubin alterations
Stent reabsorption: radiographic persistence of stent radiopaque marks
时间窗: 12 months
Radiography
次要结局
未报告次要终点