Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 7
- 主要终点
- The diagnostic value of the wireless colon capsule endoscopy
研究概览
简要总结
The incidence of Inflammatory Bowel Diseases (IBD) is in a continuous progression both in adults as in children. The colonoscopy is considered as the gold standard exam for the diagnosis and the follow-up of the patients presenting or suspected to have an IBD. The follow-up and financial management of this kind of pathology is very much dependent on the quality of the endoscopic images. Because colonoscopy is an expensive and invasive technique which assumes a general sedation, many efforts have been done to develop new less expensive and less invasive techniques in order to offer alternatives to the classic colon endoscopy. One of these new techniques is the colon videocapsule (CVC) endoscopy (PillCam® colon 2 - Given Imaging, Yoqneam, Israel). This is a new promising semi-invasive endoscopic technique which has been successfully validated with adults. We hypothesize that the CVC can be used in children with similar results in terms of efficacy, as is the case for adults.
This prospective simple blind multicenter study, will investigate the diagnostic value of the CVC compared to the conventional colonoscopy under general sedation for the detection and the control of colon lesions in children presenting IBD.
If the feasibility and the efficacy of the colon video capsule technique are also proven for use with children, then this new technique might become a very interesting alternative for the endoscopic examination of the colon because of being less expensive and less invasive.
Moreover, this technique would be very useful as a means of lesions detection all along the digestive tract and not limited to the colon only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Will be included in this study are patients:
- •Presenting a suspected or confirmed Inflammatory Bowel Disease (IBD) such as Crohn Disease, Ulcerative Colitis or undetermined colitis and who are referred for a conventional colonoscopy;
- •Between 8 and 18 years old
- •Who are not participating in other clinical trials
- •For who a written informed consent was obtained
- •Having successfully performed a candy test and the bowel permeability test (using the Patency Alagile ® capsule)
排除标准
- •Will not be included in this study are patients:
- •Presenting a contra indication for colonoscopy under general sedation or for the ingestion of the colon video capsule, especially those for who exist a clinical or radiological suspicion of upper gastrointestinal strictures (esophageal surgery or eosinophil esophagitis) and who presents a dysphagia to solids, swallowing disorders with or without impaired consciousness.
- •Who underwent an abdominal surgery during the last 3 months prior to the inclusion visit or who presents signs of bowel stenosis or occlusion
- •Who presents a toxic mega colon, radic enteritis, intestinal bowel carcinoma or who receives a chronically non-steroidal anti-inflammatory treatment
- •Presenting a contra indication for the bowel preparation agents
- •With cardiac pacemaker or other implanted electro medical devices susceptible to interfere with the colon video capsule
- •Scheduled for a magnetic resonance imaging (MRI) examination within 7 days following the ingestion of the colon video capsule (and until the evacuation of the capsule has been confirmed) or any other life-threatening conditions
研究组 & 干预措施
video capsule endoscopy
干预措施: Colon videocapsule endoscopy (PillCam colon 2) (Device)
结局指标
主要结局
The diagnostic value of the wireless colon capsule endoscopy
时间窗: 1 week after the completion of the colon video capsule exam .
The diagnostic value of the colon video capsule will be estimated based upon the calculated sensitivity of the colon video capsule for the detection and the control of colon lesions in children presented with IBD compared to the colonoscopy sensitivity.
次要结局
- Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation(1 week after the completion of the colon video capsule exam)
- Diagnostic performance of the colon video capsule(1 week after the completion of both endoscopic exams)
- Diagnostic and predictive value of the colon video capsule(1 week after the completion of the colon video capsule exam)
- Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon(1 week after the colon video capsule has been performed)
- Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel(1 week after the colon video capsule has been performed)