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

NCT ID: NCT00492791

Last Updated: 2012-04-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 158 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2011-12-31

Brief Summary

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

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.

Conditions

Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic Capsule

Patient enrolled for performing an endoscopic capsule

wireless endoscopy capsule

Intervention Type: DEVICE

Firslty patency ingestion then wireless endoscopy capsule exam done

Interventions

wireless endoscopy capsule

Firslty patency ingestion then wireless endoscopy capsule exam done

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arnaud BOURREILLE, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Locations

Ulb - Clinique Saint Luc

Brussels, , Belgium

Gent University Hospital

Ghent, , Belgium

CHU LIEGE - Sart Tilman

Liège, , Belgium

Chu Amiens

Amiens, , France

Chu Besancon

Besançon, , France

Hopital Saint Andre

Bordeaux, , France

CHU CAEN

Caen, , France

Hopital Beaujon

Clichy, , France

Chru Lille

Lille, , France

Chu Nantes

Nantes, , France

CHU NICE

Nice, , France

Hopital Lariboisiere

Paris, , France

Hopital Saint Louis

Paris, , France

Hopital St Antoine

Paris, , France

Hopital Georges Pompidou

Paris, , France

Institut Mutualiste Montsouris (Imm)

Paris, , France

Chu Rouen

Rouen, , France

Chu Saint Etienne

Saint-Etienne, , France

Chu Strasbourg

Strasbourg, , France

Chu Tours

Tours, , France

Countries

Belgium; France

Related Links

http://www.getaid.org/

Related Info

Other Identifiers

GETAID 2006-2

Identifier Type: -

Identifier Source: org_study_id