Colon Capsule Endoscopy in Children

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease

Conditions
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Inflammatory Bowel Disease

Intervention / Treatment
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* Device: Colon videocapsule endoscopy (PillCam colon 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: video capsule endoscopy<br> | Device: Colon videocapsule endoscopy (PillCam colon 2)<br>* This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease. Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians. In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a comfort score questionnaire. In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy.<br>* Other names: PillCam colon 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic value of the wireless colon capsule endoscopy | 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. | 1 week after the completion of the colon video capsule exam . | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic and predictive value of the colon video capsule | The diagnostic value expressed by the specificity, positive and negative predictive values of the colon video capsule compared to the results of the colonoscopy under general sedation. | 1 week after the completion of the colon video capsule exam | 
| Diagnostic performance of the colon video capsule | Percentage of the colon lesions successfully detected by the colon video capsule compared to the results recorded during the colonoscopy. | 1 week after the completion of both endoscopic exams | 
| Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation | Based upon the comfort score calculated after a comfort questionnaire that the patient has been completed after the colon video capsule exam and colonoscopy have been performed | 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 | The evaluation will be done using the Boston score. | 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 | The analysis will be based upon the description of the different lesions and the time of capsule progression in each bowel segment during the video capsule exam. The different segments will be defined taking into account the anatomic landmarks. | 1 week after the colon video capsule has been performed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy