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

Phase 4

Completed

• Conditions: Crohn Disease
• Interventions: Procedure: Colon Capsule Endoscopy

• Registration Number: NCT01183845
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-09-11
• Study First Submitted QC: 2010-08-16
• Study First Posted: 2010-08-18
• Status Verified: 2011-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2015-04-26
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exam with colon capsule	Colon Capsule Endoscopy	Colon Capsule Endoscopy

Primary Outcome Measures

Name	Time	Method
Data obtained by the colon capsule endoscopy as a Measure of safety	1 month

Secondary Outcome Measures

Name	Time	Method
Reproducibility of the identification of the different anatomic segments on the CCE recordings	1 month
Reproducibility of the detection of each lesion	At inclusion

Trial Locations

Locations (3)

Hopital Beaujon; 🇫🇷 Clichy, France

Chru Lille; 🇫🇷 Lille, France

Chu Nantes; 🇫🇷 Nantes, France