Clinical Impact of Longer Battery Life on Small Bowel Capsule Endoscopy: a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Completion Rate (Rate at Which Small Bowel is Completely Examined)
研究概览
简要总结
Capsule endoscopy (CE) is a non-invasive means of visualizing the small bowel. Common indications for CE include obscure gastrointestinal (GI) bleeding, inflammatory bowel disease like crohn's disease or ulcerative colitis, celiac disease, and polyposis syndrome.
While CE has high diagnostic value for small bowel lesions, a significant limitation of this technology is the finite battery life which results in incomplete examination of the small bowel approximately 16.5% of the time. Numerous attempts of using pharmacological (e.g. prokinetics, purgatives) as well as non-pharmacological measures (e.g. real-time viewer, chewing gum) to improve completion rates, defined by entry of CE into the cecum, led to mixed results. Currently routine use of prokinetics (agents that speeds up gut motility) is not recommended.
This study aims to determine whether longer battery of the newer generation capsule endoscopy system improves study completion rate and diagnostic yield.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 19 or greater who are referred for small bowel capsule endoscopy
- •Willing and able to provide written informed consent
排除标准
- •Unwillingness or inability to swallow pill
- •Known or suspected obstruction or bowel stricture
- •Endoscopic placement of capsule camera
- •Concomitant enrollment in a prospective study in the treatment arm receiving prokinetics for the purpose of enhancing bowel motility. (i.e. control arm not receiving any motility-enhancing agent can be included)
结局指标
主要结局
Completion Rate (Rate at Which Small Bowel is Completely Examined)
时间窗: 0.1 - 12 hours
rate at which small bowel is completely examined (capsule endoscopy enters cecum)
次要结局
- Diagnostic Yield(0.1 - 12 hours)
- Small Bowel Transit Time(0.1 - 12 hours)
- Gastric Transit Time(0.1 - 12 hours)
研究者
Robert Enns
Clinical Professor
University of British Columbia