跳至主要内容
临床试验/NCT01410071
NCT01410071终止不适用

Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care

Wisconsin Center for Advanced Research1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2005年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
153
试验地点
1
主要终点
symptom improvement

研究概览

简要总结

The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.

详细描述

Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures >40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.

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

入选标准

  • over age 18
  • suspected history and clinical features suggestive of sphincter of oddi dysfunction

排除标准

  • prior history of endoscopic therapy for sphincter of oddi dysfunction
  • no proven sphincter of oddi dysfunction on manometry

结局指标

主要结局

symptom improvement

时间窗: one year

次要结局

  • improved quality of life(one year)

研究者

发起方
Wisconsin Center for Advanced Research
申办方类型
Other

研究点 (1)

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