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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase

Completed

Phase 4

Conditions

Crohn Disease

Treatments

Procedure: Colon Capsule Endoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01183845

GETAID 2008-2

Details and patient eligibility

About

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.

Full 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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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