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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: Colon Capsule Endoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exam with colon capsule<br>Colon Capsule Endoscopy | Procedure: Colon Capsule Endoscopy<br>* Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data obtained by the colon capsule endoscopy as a Measure of safety |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn Disease, Crohn's Disease Endoscopy Index of Severity, Colon Capsule Endoscopy, Crohn's Disease located in colon and/or ileum