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Completed

NCT Number: NCT01183845

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital Beaujon, Clichy, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colon Capsule Endoscopy

Procedure

Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.

Primary outcomes

  1. Data obtained by the colon capsule endoscopy as a Measure of safety

    Time frame: 1 month

Secondary outcomes

  1. Reproducibility of the identification of the different anatomic segments on the CCE recordings

    Time frame: 1 month

  2. Reproducibility of the detection of each lesion

    Time frame: At inclusion

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study title

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

Acronym: CAPSCOL

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 18, 2010
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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