A Pilot Study to Evaluate the Applicability of the Crohn's Disease Endoscopy Index of Severity to Data Obtained by the Colonic Capsule Endoscopy in Ileocolonic Crohn's Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 6
- 主要终点
- Data obtained by the colon capsule endoscopy as a Measure of safety
研究概览
简要总结
The Crohn's Disease Endoscopic Index of Severity is a validated index to assess the severity of ileocolonic lesions. Depth of ulcerations are evaluated in each segment of ileocolon and the surface of lesions and ulcerations are reported on a 10-cm analogic scale. The Crohn's Disease Endoscopic Index of Severity is the main score used in controlled trials to assess the endoscopic severity of lesions in Crohn's Disease.
The investigators aim to conduct a prospective pilot study primarily to evaluate the applicability of the Crohn's Disease Endoscopic Index of Severity to data obtained by the colonic capsule endoscopy procedure, provided that conventional ileo-colonoscopy and capsule endoscopy lead to comparable overall severity evaluations.
Secondary objectives are to assess reproducibility of the reading of data obtained by CCE and to compare these data with those obtained by conventional ileocolonoscopy. If overall severity evaluations derived from the two examinations are not comparable, the secondary objectives will be used in an attempt to understand the reasons of this discrepancy.
详细描述
Twenty-four patients with CD will be included in the study on the basis of the need for an ileo-colonoscopy whatever the indication.
- Males and females patients more than 18-years-old
- Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
- Ileocolonoscopy scheduled
- Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy.
- Previous imaging of small bowel (one or more) by Small Bowel Follow Through (SBFT), Magnetic Resonance Enteroclysis (MRE) or Computed Tomography Enterography (CTE) performed in the last 12 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females patients more than 18-years-old
- •Known colonic CD patients with a diagnosis based on established clinical, endoscopic, ra-diologic, and histologic criteria
- •Ileocolonoscopy scheduled
- •Patients' agreement for the CCE procedure to be performed within the week following the ileocolonoscopy
排除标准
- •Surgery of one or more segment of the colon or terminal ileum
- •Non colonic CD
- •High risk for capsule retention defined by the presence of clinically significant obstructive symptom related to intestinal or colonic stricture detected by small bowel imaging
- •Stenosis of the colon or ileum not passed by the colonoscope
- •Treatment with antiTNF or biotherapy after the ileocolonoscopy and before the CCE procedure
结局指标
主要结局
Data obtained by the colon capsule endoscopy as a Measure of safety
时间窗: 1 month
次要结局
- Reproducibility of the identification of the different anatomic segments on the CCE recordings(1 month)
- Reproducibility of the detection of each lesion(At inclusion)