Clinical trial NCT00492791: Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
Official title: Development and Validation of an Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: crohn's disease
capsule endoscopes
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
First posted: 2007-06-27
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active or quiescent Crohn's Disease

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.

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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Ulb - Clinique Saint Luc
city: Gent
country: Belgium
facility: Gent University Hospital
city: Liege
country: Belgium
facility: CHU LIEGE - Sart Tilman
city: Amiens
country: France
facility: Chu Amiens
city: Besancon
country: France
facility: Chu Besancon
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Caen
country: France
facility: CHU CAEN
city: Clichy
country: France
facility: Hopital Beaujon
city: Lille
country: France
facility: Chru Lille
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: CHU NICE
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital St Antoine
city: Paris
country: France
facility: Hopital Georges Pompidou
city: Paris
country: France
facility: Institut Mutualiste Montsouris (Imm)
city: Rouen
country: France
facility: Chu Rouen
city: St Etienne
country: France
facility: Chu Saint Etienne
city: Strasbourg
country: France
facility: Chu Strasbourg
city: Tours
country: France
facility: Chu Tours
Study officials:
affiliation: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
name: Arnaud BOURREILLE, MD
role: PRINCIPAL_INVESTIGATOR
References: