NCT01543256已完成不适用
A Multi-Center, Prospective, Randomized Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 27
- 主要终点
- Number of Participants With Stricture Resolution
研究概览
简要总结
The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months.
Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.
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
- 是
入选标准
- •Age 18 or older
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Chronic pancreatitis
- •Symptomatic bile duct stricture (defined by cholangitis or persistent jaundice for at least one month or cholestasis associated with at least 3 times normal alkaline phosphatase levels) documented at time of enrollment for naïve stricture or at the time of prior plastic stent placement in strictures that had one prior plastic stent inserted.12
- •Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts
排除标准
- •Biliary stricture of benign etiology other than chronic pancreatitis
- •Prior biliary metal stent or any plastic stenting other than one plastic stent of 10 Fr or less for 6 months or fewer
- •Developing obstructive biliary symptoms associated with an attack of acute pancreatitis
- •Biliary stricture of malignant etiology
- •Stricture within 2 cm of common bile duct bifurcation
- •Known bile duct fistula or leak
- •Subjects for whom endoscopic techniques are contraindicated
- •Known sensitivity to any components of the stent or delivery system
- •Symptomatic duodenal stenosis (with gastric stasis)
- •Participation in another investigational study within 90 days prior to consent
- •Investigator Discretion
结局指标
主要结局
Number of Participants With Stricture Resolution
时间窗: After 12-month stenting period through 24 month follow-up (approximately 12 months)
Stricture resolution defined as absence of re-stenting after the 12-month stenting period, and 24 months serum alkaline phosphatase level not exceeding twice the level at the end of stenting period.
次要结局
- Number of ERCP Procedures Through 24 Months After Initial Stent Placement.(Initial stent placement procedure to 24 month follow-up)
- Number of Stents Placed(Initial stent placement procedure to 24 month follow-up)
- Serious Adverse Events Related to the Device or Procedure(Initial stent placement procedure to 24 month follow-up)
- Ability to Deploy Stent(s) in Satisfactory Position (Technical Success)(Initial stent placement procedure)
- Length of Stent Placement and Removal Procedures(Initial stent placement procedure to 24 month follow-up)
研究者
研究点 (27)
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