Clinical trial NCT02129972: Colon Capsule Endoscopy in Children
Official title: Evaluation of the Video Capsule Colonoscopy for the Detection and the Control of Colon Lesions in Children Presenting Confirmed or Suspected Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Keywords: Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 52
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The diagnostic value of the wireless colon capsule endoscopy
timeFrame: 1 week after the completion of the colon video capsule exam .
Secondary outcomes:
measure: Diagnostic and predictive value of the colon video capsule
timeFrame: 1 week after the completion of the colon video capsule exam
measure: Diagnostic performance of the colon video capsule
timeFrame: 1 week after the completion of both endoscopic exams
measure: Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation
timeFrame: 1 week after the completion of the colon video capsule exam
measure: Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon
timeFrame: 1 week after the colon video capsule has been performed
measure: Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel
timeFrame: 1 week after the colon video capsule has been performed
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
city: Bron
country: France
facility: Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
city: Lille
country: France
facility: Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
city: Paris
country: France
facility: Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
city: Paris
country: France
facility: Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
city: Rennes
country: France
facility: Service de Pédiatrie, Hôpital Sud, CHU de Rennes
city: Toulouse
country: France
facility: Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse
Study officials:
affiliation: HOPITAL FEMME MERE ENFANT CHU DE LYON
name: ALAIN LACHAUX, MD
role: PRINCIPAL_INVESTIGATOR
References: