NCT01183845

Evaluation of the Applicability of the CDEIS to Data Obtained by the Colonic Capsule Endoscopy in Crohn Disease

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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

Conditions

• Crohn Disease

Interventions

Type	Name	Description
PROCEDURE	Colon Capsule Endoscopy	Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-08-18
• Last updated: 2015-04-28

Locations

3 sites across 1 country: France