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
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 investigatorâ??s ability to evaluate the patientâ??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.
研究者
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