跳至主要内容
临床试验/NCT02315404
NCT02315404终止不适用

Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2014年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
87
试验地点
2
主要终点
Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).

研究概览

简要总结

Gastrointestinal bleeding originating from the small bowel is difficult to diagnose and treat because the small bowel is difficult to see and reach. Balloon assisted enteroscopy (BAE) is a new enteroscopy methods that allow examination of the small bowel and allows for diagnosis and treatment of bleeding originating from this part of the intestine. Unfortunately, BAE is unsuccessful in identifying the cause of bleeding in 40-50% of patients. This may be due to limited visualization of the small bowel lining during conventional endoscopy. One way to improve visualization of the small bowel lining is by adding a transparent plastic cap to the end of the endoscope (camera), which allows the endoscope to see around sharp turned and behind folds in the small bowel.

The investigators goal in this randomized controlled study is to see if adding a transparent cap to the end of the endoscope will help to identify and treat small bowel bleeding. The investigators will invite patients referred for BAE to participate in the study; the alternative to participating in the study is having standard BAE (without a cap). If patients choose to participate in the study they will be randomized to BAE with or without a cap on the end of the endoscope. Subjects time commitment will be limited to the consent process and pre-procedure paperwork at time of initial endoscopy and time required to complete telephone questionnaire at 12 months follow up.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (≥18 years old) patients undergoing BAE for the evaluation of OGIB or iron deficiency anemia.

排除标准

  • Unable to provide written informed consent.
  • Pregnancy or lactation.
  • Suspected bowel obstruction or GI perforation.
  • Unable to tolerate sedation or general anesthesia due to medical co-morbidities.
  • Uncorrected coagulopathy (platelet count <50,000, INR> 2, PTT> 2x upper limit of normal).
  • Patient undergoing retrograde BAE.

研究组 & 干预措施

No cap

Placebo Comparator

enteroscopy performed without a cap

干预措施: CAP (Procedure)

Enteroscopy with a cap

Active Comparator

Enteroscopy performed with a CAP fitted to the end of the scope

干预措施: CAP (Procedure)

结局指标

主要结局

Diagnostic yield of BAE vs. Cap assisted BAE (C-BAE).

时间窗: 1 day

Diagnostic yield defined as proportion of enteroscopies in which clinically significant findings were identified. a. Clinically significant findings being defined as P2 lesion (lesion considered to have high potential for bleeding; such as typical angiomata, large ulceration, tumor or varices)

次要结局

  • Overall Diagnostic yield of BAE vs. C-BAE(1 day)
  • iii. Depth of small bowel insertion: calculated according to the method of Efthymiou et al.(1 day)
  • Therapeutic yield BAE vs. Cap assisted BAE (C-BAE).(1 day)
  • vProcedure related adverse events.(1 day)
  • Recurrence of GI bleeding at 12 months, as evaluated by questionnaire(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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