The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Number of participants with extent and severity of colonic inflammation
研究概览
简要总结
The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.
详细描述
Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •suspected or known UC
- •written informed consent
排除标准
- •patients with severe UC according to Truelove and Witts' criteria
- •current pregnancy/lactating
- •patients with a pacemaker or other implanted electromedical device
- •the presence of dysphagia
- •patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation)
- •patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition)
- •patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository
研究组 & 干预措施
C2 & colonoscopy
C2 and colonoscopy
干预措施: colonoscopy (Procedure)
C2 & colonoscopy
C2 and colonoscopy
干预措施: C2 (Device)
结局指标
主要结局
Number of participants with extent and severity of colonic inflammation
时间窗: 1 day
extent and severity of mucosal inflammation will be assessed by each investigation
次要结局
未报告次要终点
研究者
Siew Chien NG
Professor
Chinese University of Hong Kong