Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy (NCT00492791) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Severity Score of Small Bowel Crohn's Disease With Wireless Capsule Endoscopy
Belgium, France158 participantsStarted 2007-03
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00492791
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives