Crohn Disease
Conditions
Keywords
Crohn Disease, Crohn's Disease Endoscopy Index of Severity, Colon Capsule Endoscopy, Crohn's Disease located in colon and/or ileum
Brief 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
Interventions
PROCEDUREColon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Sponsors
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Data obtained by the colon capsule endoscopy as a Measure of safety | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| Reproducibility of the identification of the different anatomic segments on the CCE recordings | 1 month |
| Reproducibility of the detection of each lesion | At inclusion |
Countries
France
Outcome results
None listed