Randomized Controlled Trial of Wireless Capsule Endoscopy in the Evaluation of Obscure Gastrointestinal Bleeding
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Further bleeding
研究概览
简要总结
This study compares wireless capsule endoscopy (patients swallow a pill-size camera that sends pictures of the intestine to a recorder worn on their belt) to an x-ray study (called dedicated small bowel contrast radiography) in patients who have bleeding from the gastrointestinal tract without a source of the bleeding identified on routine endoscopic examinations of the esophagus (food pipe), stomach, small intestine, and large intestine.
The investigators hope to determine if the capsule is a better test in terms of decreasing further bleeding, decreasing the need for further diagnostic testing, and decreasing the need for blood transfusions and time spent in the hospital.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Iron deficiency anemia in men or post-menopausal women and positive fecal occult blood test in pre-menopausal women with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
- •Persistent or recurrent melena or hematochezia with nondiagnostic upper endoscopy, colonoscopy, and push enteroscopy.
排除标准
- •Known or suspected GI tract obstruction
- •Severe motility disorders (e.g., achalasia, gastroparesis, pseudoobstruction)
- •Cardiac pacemaker or implanted electro-medical devices
研究组 & 干预措施
1
Capsule Endoscopy
干预措施: Capsule endoscopy (Other)
2
Dedicated small bowel contrast radiography
干预措施: Dedicated small bowel contrast radiography (Other)
结局指标
主要结局
Further bleeding
时间窗: 1 year
次要结局
- Diagnostic yield(1 year)