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Colon Capsule Endoscopy in Children (VICCOINBODI)

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ClinicalTrials.gov Identifier: NCT02129972
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Device: Colon videocapsule endoscopy (PillCam colon 2) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : April 2014
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: video capsule endoscopy Device: Colon videocapsule endoscopy (PillCam colon 2)

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.

Other Name: PillCam colon 2




Primary Outcome Measures :
  1. The diagnostic value of the wireless colon capsule endoscopy [ Time Frame: 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.


Secondary Outcome Measures :
  1. Diagnostic and predictive value of the colon video capsule [ Time Frame: 1 week after the completion of the colon video capsule exam ]
    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.

  2. Diagnostic performance of the colon video capsule [ Time Frame: 1 week after the completion of both endoscopic exams ]
    Percentage of the colon lesions successfully detected by the colon video capsule compared to the results recorded during the colonoscopy.

  3. Evaluation of the feasibility and the acceptability by the patient of the colon video capsule compared to the colonoscopy under general sedation [ Time Frame: 1 week after the completion of the colon video capsule exam ]
    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

  4. Evaluation of the efficacy of the bowel preparation before the endoscopic examination of the colon [ Time Frame: 1 week after the colon video capsule has been performed ]
    The evaluation will be done using the Boston score.

  5. Descriptive analysis of the visualization and the progression of the colon video capsule over the different segments of the bowel [ Time Frame: 1 week after the colon video capsule has been performed ]
    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.



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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129972


Locations
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France
Service de Pédiatrie Médicale, Hôpital Pellegrin, CHU de Bordeaux
Bordeaux, France
Service d'Hépatologie, gastroentérologie et nutrition pédiatrique, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Bron, France
Clinique de Pédiatrie, Hôpital Jeanne de Flandre, CHU de Lille
Lille, France
Service de Gastroentérologie, Mucoviscidose et Nutrition, Hôpital Robert Debré, AP-HP
Paris, France
Service de Hépato Gastroentérologie et Nutrition, Hôpital Necker Enfants Malades, AP-HP
Paris, France
Service de Pédiatrie, Hôpital Sud, CHU de Rennes
Rennes, France
Service de Gastroentérologie, Hépatologie, Nutrition et Diabétologie, Hôpital des Enfants, CHU de Toulouse
Toulouse, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: ALAIN LACHAUX, MD HOPITAL FEMME MERE ENFANT CHU DE LYON

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02129972     History of Changes
Other Study ID Numbers: 2013-823
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: October 2018

Keywords provided by Hospices Civils de Lyon:
Inflammatory Bowel Disease, colon lesions, colon capsule endoscopy

Additional relevant MeSH terms:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis