Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease (CAPSCOL)
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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.
Condition | Intervention | Phase |
---|---|---|
Crohn Disease |
Procedure: Colon Capsule Endoscopy |
Phase 4 |
Study Type: | Interventional |
Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
Official Title: | 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 |
- Data obtained by the colon capsule endoscopy as a Measure of safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Reproducibility of the identification of the different anatomic segments on the CCE recordings [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- Reproducibility of the detection of each lesion [ Time Frame: At inclusion ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 24 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Exam with colon capsule
Colon Capsule Endoscopy
|
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
|
Detailed Description:
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
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
France | |
Hopital Beaujon | Recruiting |
Clichy, France, 92110 | |
Contact: Yoram BOUHNIK, MD,PhD +33 1 40 87 56 00 yoram.bouhnik@bjn.aphp.fr | |
Principal Investigator: YORAM BOUHNIK, MD,PhD | |
Sub-Investigator: Alain ATTAR, MD | |
Sub-Investigator: Carmen STEFANESCU, MD | |
Sub-Investigator: Xavier TRETON, MD | |
Chru Lille | Recruiting |
Lille, France, 59037 | |
Contact: Jean-Frédéric COLOMBEL, MD,PhD +33 3 20 44 47 14 jean-frederic-colombel@chru-lille.fr | |
Contact: Géraldine MEULIN +33 3 20 44 56 20 g-meulin@chru-lille.fr | |
Principal Investigator: Jean-Frédéric COLOMBEL, MD,PhD | |
Sub-Investigator: Gwenola VERNIER-MASSOUILLE, MD | |
Chu Nantes | Recruiting |
Nantes, France, 44093 | |
Contact: Arnaud BOURREILLE, MD +33202400830 arnaud.boureille@chu-nantes.fr | |
Principal Investigator: Arnaud BOURREILLE, MD | |
Sub-Investigator: Mathurin FLAMANT, MD |
Study Director: | LEMANN Marc | GETAID |
Principal Investigator: | Alain ATTAR, MD | GETAID |
Additional Information:
Publications:
Responsible Party: | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
ClinicalTrials.gov Identifier: | NCT01183845 History of Changes |
Other Study ID Numbers: | GETAID 2008-2 |
Study First Received: | September 11, 2009 |
Last Updated: | August 30, 2011 |
Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
Crohn Disease Crohn's Disease Endoscopy Index of Severity Colon Capsule Endoscopy Crohn's Disease located in colon and/or ileum |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on October 17, 2012