Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy (CAPSCDEIS)

April 16, 2012 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy

The endoscopic capsule is a new tool for exploration of the small intestine. The superiority of this technique on the radiological conventional examinations was shown in Crohn's disease. However no standardization of the lesions exists and no score of severity was proposed. The objective of this exploratory and multicentric study is to develop and validate an endoscopic score of severity especially dedicated to the examination by endoscopic capsule of the small intestine. Hundred twenty patients reached of disease of Crohn corresponding to various groups of severity will be included and will have an examination by video-capsule. The recorded examinations will be the standardized collection of all the lesions observed by independent readers, which will make it possible to evaluate the level of reproducibility of the detection of each lesion. Moreover, each reader will provide his total, qualitative and quantitative evaluations, of the severity of the attack of the small intestine. By using the data of only one reader, a score of severity will be built by simple linear function of the reproducible lesions observed. This score will be validated from the data corresponding to other readers of the same examinations, and those corresponding to another sample. Lastly, the aptitude of this score to detect the changes of the severity of the attack of the small intestine and to define the endoscopic cicatrization will be evaluated from data obtained among patients before and after treatment by infliximab or corticoids

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

primary objective:Development and validation of an endoscopic score of severity of the small intestine adapted to its exploration by capsule among patients with crohn's disease secondary objectives:

  • Study of the reproducibility of the detection of the lesions
  • total evaluation of the severity of the small intestine (on an ordinal scale with 5 classes and on a continuous analogical scale).
  • Study and validation of the sensitivity to the change of the score of severity (variation among patients after treatment by Infliximab or corticoids).
  • Evaluation of the aptitude of the endoscopic score of severity to define the endoscopic cicatrization.
  • Study of the correlation between the endoscopic score of severity and a clinical marker of activity: Crohn' S Disease Activity Index (CDAI) and a marker of inflammation: serum level of C-Reactive protein (CRP).
  • Validation of the utility of "Patency Agile™" used before the capsule. All the patients included will have before their endoscopic capsule an examination by patency. After validation, the patients will have an exploration by the video capsule. The readers will fill a grid with standardized lesions. The films will be read by two other independent readers. The patients treated by infliximab or prednisone will have one second capsule afterwards 10 weeks.

Study Type

Observational

Enrollment (Actual)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Ulb - Clinique Saint Luc
      • Gent, Belgium, 9000
        • Gent University Hospital
      • Liege, Belgium, 4000
        • CHU Liège - Sart Tilman
  • France
      • Amiens, France, 80054
        • CHU Amiens
      • Besancon, France, 25030
        • CHU Besançon
      • Bordeaux, France, 33075
        • Hopital Saint André
      • Caen, France, 14033
        • CHU Caen
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Lille, France, 59037
        • CHRU lille
      • Nantes, France, 44093
        • CHU Nantes
      • Nice, France, 06202
        • CHU Nice
      • Paris, France, 75010
        • Hôpital Saint Louis
      • Paris, France, 75010
        • Hôpital Lariboisiere
      • Paris, France, 75012
        • Hôpital St Antoine
      • Paris, France, 75015
        • Hopital Georges Pompidou
      • Paris, France, 75674
        • Institut Mutualiste Montsouris (IMM)
      • Rouen, France, 76031
        • CHU Rouen
      • St Etienne, France, 42270
        • CHU Saint Etienne
      • Strasbourg, France, 67091
        • CHU Strasbourg
      • Tours, France, 37044
        • Chu Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Active or quiescent Crohn's Disease

Description

Inclusion Criteria:

  • Patients older than 18 years.
  • Crohn's disease diagnosed on clinical, endoscopic, histological criteria. In active or inactive phase of their disease (HBI > 4; CDAI > 150).
  • The patients will belong to the one of the 4 groups defined above according to the examinations carried out during the follow-up of the disease.
  • Group 1: at least one ileal ulceration at ileocolonoscopy and no radiological abnormality
  • Group 2: nonsevere attack on radiological examinations with or without endoscopic lesion
  • Group 3: severe attack on radiological examinations with or without endoscopic lesion.
  • Group 4: no lesion neither in endoscopy nor on radiologic exams.
  • Small intestine standard exploration less than 1 year.
  • Affiliation with the social security or a mode of social protection.
  • able to understand and sign an informed consent.

Exclusion Criteria:

  • ano-perineal location.
  • Occlusion or sub-occlusion chronicle or intermittent or if there are frank signs of dilation of small intestine on the morphological examinations.
  • Martial treatment since less than ten days before the realization of the capsule.
  • Non steroidal anti-inflammatory treatment since less than three months before the realization of the capsule.
  • Ileostomy on hail.
  • Pace-maker or another implantable device.
  • Swallowing troubles.
  • Non evacuation of the Patency capsule in the 48 hours.
  • Occlusion during the passage of the patency capsule.
  • pregnant woman.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopic Capsule
Patient enrolled for performing an endoscopic capsule
Device: wireless endoscopy capsule
Firslty patency ingestion then wireless endoscopy capsule exam done

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Investigators

  • Principal Investigator: Arnaud BOURREILLE, MD, Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 26, 2007

First Submitted That Met QC Criteria

June 26, 2007

First Posted (Estimate)

June 27, 2007

Study Record Updates

Last Update Posted (Estimate)

April 17, 2012

Last Update Submitted That Met QC Criteria

April 16, 2012

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID 2006-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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