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

This study is currently recruiting participants.
Verified August 2011 by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT01183845
First received: September 11, 2009
Last updated: August 30, 2011
Last verified: August 2011

September 11, 2009
August 30, 2011
April 2009
June 2012   (final data collection date for primary outcome measure)
Data obtained by the colon capsule endoscopy as a Measure of safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01183845 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

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
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Crohn Disease
Procedure: Colon Capsule Endoscopy
Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
Experimental: Exam with colon capsule
Colon Capsule Endoscopy
Intervention: Procedure: Colon Capsule Endoscopy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
France
 
NCT01183845
GETAID 2008-2
No
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Not Provided
Study Director: LEMANN Marc GETAID
Principal Investigator: Alain ATTAR, MD GETAID
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP