CTRI/2012/11/003103已完成4 期
A Multi-Center, Prospective, Randomized Phase 3 Study Comparing Removable, Self-Expanding Metal Stents to Plastic Stents for the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Stricture resolution at 24 months
研究概览
简要总结
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 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. The null hypothesis is that the stricture resolution rate is non-inferior in the Metal Stent Arm versus the Plastic Stent Arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study Chronic pancreatitis Stricture not previously dilated Symptomatic bile duct stricture Common bile duct stricture based on imaging assessment of dilatation of the common and/or intrahepatic bile ducts.
排除标准
- •Stricture within 2 cm of the upper esophageal sphincter.
- •Dysphagia related to motility disorder.
- •Non-anastomotic esophageal strictures.
- •Esophagocolonic strictures.
- •Planned adjuvant radiation therapy post esophagectomy.
- •Prior esophageal stent placements post esophagectomy.
- •Active erosive esophagitis.
- •Sensitivity to any components of the stent or delivery system.
- •Concurrent medical condition that would affect the investigator’s ability to evaluate the patient’s condition or could compromise patient safety.
- •Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
- •Stricture length 5 cm.
结局指标
主要结局
Stricture resolution at 24 months
时间窗: 24 months following initial study treatment
次要结局
- Occurence of adverse events(Number of ERCP procedures)
研究者
研究点 (1)
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