Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease (CAPSCOL)
Recruitment status was Recruiting
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.
|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 ]
|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)|
Experimental: Exam with colon capsule
Colon Capsule Endoscopy
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01183845
|Clichy, France, 92110|
|Contact: Yoram BOUHNIK, MD,PhD +33 1 40 87 56 00 firstname.lastname@example.org|
|Principal Investigator: YORAM BOUHNIK, MD,PhD|
|Sub-Investigator: Alain ATTAR, MD|
|Sub-Investigator: Carmen STEFANESCU, MD|
|Sub-Investigator: Xavier TRETON, MD|
|Lille, France, 59037|
|Contact: Jean-Frédéric COLOMBEL, MD,PhD +33 3 20 44 47 14 email@example.com|
|Contact: Géraldine MEULIN +33 3 20 44 56 20 firstname.lastname@example.org|
|Principal Investigator: Jean-Frédéric COLOMBEL, MD,PhD|
|Sub-Investigator: Gwenola VERNIER-MASSOUILLE, MD|
|Nantes, France, 44093|
|Contact: Arnaud BOURREILLE, MD +33202400830 email@example.com|
|Principal Investigator: Arnaud BOURREILLE, MD|
|Sub-Investigator: Mathurin FLAMANT, MD|
|Study Director:||LEMANN Marc||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|
|Principal Investigator:||Alain ATTAR, MD||Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives|