Cap Assisted Balloon Enteroscopy Versus Conventional Balloon Enteroscopy In The Evaluation Of Obscure Gastrointestinal Bleeding: A Randomized Controlled Trial
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
- 否
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
enteroscopy performed without a cap
干预措施: CAP (Procedure)
Enteroscopy with a cap
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)
