NCT04805450招募中不适用
A Prospective, Randomized, Multicenter Study Comparing Sems Placement With and Without Biliary Sphincterectomy in Patients With Malignant Biliary Obstruction
Istituto Clinico Humanitas2 个研究点 分布在 1 个国家目标入组 1,075 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,075
- 试验地点
- 2
- 主要终点
- To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
研究概览
简要总结
Placement of biliary self expanding metal stent (SEMS) is indicated when malignant common bile duct obstruction is encountered [1]. Currently, there is still controversy regarding the use of endoscopic sphincterotomy (EST) before the placement of biliary stents [2-5].
The aim of this prospective randomized, multicenter study is to investigate the role of EST before fully covered SEMS placement in patients with neoplastic biliary obstruction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Inclusion criteria
- •Patients referred for endoscopic retrograde cholangiopancreatography
- •Malignant bile duct obstruction
- •Signed written informed consent
- •Age > 18
排除标准
- •Inability to provide inform consent
- •Pregnancy or lactation
- •Suspected perforation of the GI tract
- •Anatomical alterations due to previous surgery (Billroth surgery)
- •Coagulation alterations
结局指标
主要结局
To assess the need for ES before SEMS placement in patients with malignant bile duct obstruction.
时间窗: During procedure
次要结局
- To evaluate immediate and delayed post ERCP complications including pancreatitis, SEMS migration, bleeding and perforation.(periprocedural and 30 days)
研究者
Michele Tedeschi
MD
Istituto Clinico Humanitas
研究点 (2)
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