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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier:
NCT00492791
First received: June 26, 2007
Last updated: April 16, 2012
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Crohn's Disease
Device: wireless endoscopy capsule
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy

Resource links provided by NLM:


Further study details as provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:

Enrollment: 158
Study Start Date: March 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Endoscopic Capsule
Patient enrolled for performing an endoscopic capsule
Device: wireless endoscopy capsule
Firslty patency ingestion then wireless endoscopy capsule exam done

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Active or quiescent Crohn's Disease

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492791

Locations
Belgium
Ulb - Clinique Saint Luc
Bruxelles, Belgium, 1200
Gent University Hospital
Gent, Belgium, 9000
CHU LIEGE - Sart Tilman
Liege, Belgium, 4000
France
Chu Amiens
Amiens, France, 80054
Chu Besancon
Besancon, France, 25030
Hopital Saint Andre
Bordeaux, France, 33075
CHU CAEN
Caen, France, 14033
Hopital Beaujon
Clichy, France, 92110
Chru Lille
Lille, France, 59037
Chu Nantes
Nantes, France, 44093
CHU NICE
Nice, France, 06202
Institut Mutualiste Montsouris (Imm)
Paris, France, 75674
Hopital Saint Louis
Paris, France, 75010
Hopital Georges Pompidou
Paris, France, 75015
Hopital Lariboisiere
Paris, France, 75010
Hopital St Antoine
Paris, France, 75012
Chu Rouen
Rouen, France, 76031
Chu Saint Etienne
St Etienne, France, 42270
Chu Strasbourg
Strasbourg, France, 67091
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Investigators
Principal Investigator: Arnaud BOURREILLE, MD Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
  More Information

Additional Information:
No publications provided

Responsible Party: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
ClinicalTrials.gov Identifier: NCT00492791     History of Changes
Other Study ID Numbers: GETAID 2006-2
Study First Received: June 26, 2007
Last Updated: April 16, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives:
crohn's disease
capsule endoscopes

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 26, 2014