Capsule Endoscopy or Mesenteric Angiogram in Patients With Overt Gastrointestinal Bleeding of Obscure Origin: A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
研究概览
简要总结
To compare the diagnostic yield of mesenteric angiogram with CE in patients with active obscure GIB.
详细描述
Gastrointestinal bleeding (GIB) of obscure origin is a common conditions resulting in recurrent hospitalization and extensive investigations. Mesenteric angiogram is one of the standard radiological investigations for GIB of obscure origin, and its diagnostic yield ranged from 40-80%. Capsule endoscopy (CE) is a newly available investigation for small bowel examination, especially in bleeding of obscure origin. The diagnostic yield is particularly high in patients with ongoing bleeding. This is a prospective randomized study to compare the diagnostic yield of mesenteric angiogram with CE in patients with overt GIB of obscure origin. The results will help to define the optimal management strategy for this group of patients.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients admitted to PWH medical or surgical wards with melena or hematochezia in whom OGD and colonoscopy fail to identify site of bleeding.
- •Normal or non-diagnostic OGD and colonoscopy
- •Informed consent
- •Patients presented with shock will be resuscitated for urgent endoscopy
排除标准
- •Patients remained in shock despite resuscitation.
- •Moribund patients
- •Terminal malignancy
- •Presence of pacemaker or ICD
- •Suspected or confirmed intestinal obstruction
- •Swallowing difficulties
- •Renal failure that preclude angiographic examination
- •Pregnancy
- •Refused consent
结局指标
主要结局
Diagnostic yield of CE and mesenteric angiogram as the primary investigation after negative EGD and colonoscopy.
时间窗: 12 months
次要结局
- Percentage of patients with definitive diagnoses achieved;Length of stay (days) ;Transfusion requirements;No. of additional investigations (endoscopies, radiological investigation, CE etc);No. of patients requiring surgery ;12-month rebleeding rate(12 months)