Crohn Disease Located in Jejunum or Ileum Clinical Trial
— DYDJIOfficial title:
Endoscopic Detection of Small Bowel Dysplasia and Cancer in Patients With Jejuna or Ileal Crohn Disease : Prospective Study in a Cohort of High Risk Patients
Patients with Crohn's disease (CD) have an increased risk of small bowel adenocarcinoma
(SBA). Long duration of CD is the main risk factor. SB dysplasia has been associated with
SBA in 20% of cases, always described in diseased sites. The progression to neoplasia and
natural history remains unknown but progression of inflammation to dysplasia and then to
adenocarcinoma is suspected.
As for surveillance recommendations for colorectal carcinoma in long standing inflammatory
colonic disease, endoscopic screening of SB could be proposed in CD patients with risk
factors of SBA. No study can be found in literature.
The investigators propose a multicenter exploratory open study on prospective cohort of CD
patients with high risk of dysplasia or cancer. The goal is evaluate the rate of dysplasia
and adenocarcinoma detected by enteroscopy with biopsies in a high risk CD population
| Status | Completed |
| Enrollment | 107 |
| Est. completion date | June 2014 |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - More than 18-years-old - Crohn disease on jejunum and/or ileum since at least 10 years - Radiography done during last year Exclusion Criteria: - Dysplasia previously detected - Pregnancy |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Chu Amiens | Amiens | |
| France | Chu Besancon | Besancon | |
| France | Hopital Beaujon | Clichy | |
| France | Hopital Bicetre | Le Kremlin Bicetre | |
| France | Chru Lille | Lille | |
| France | CHU NICE | Nice | |
| France | Hopital Saint Louis | Paris | |
| France | Institut Mutualiste Montsouris (Imm) | Paris | |
| France | Hopital Haut Leveque | Pessac | |
| France | CHU LYON | Pierre Benite | |
| France | Chu Rouen | Rouen | |
| France | Chu Saint Etienne | St Etienne | |
| France | Chu Toulouse | Toulouse | |
| France | Chu Tours | Tours | |
| France | Chu Nancy | Vandoeuvre Les Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
France,
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* Note: There are 14 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of dysplasia and adenocarcinoma | dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists | 2 months | No |
| Secondary | Success of endoscopic detection | the success will be measured by reaching at least one pathologic area during the endoscopic procedure | 1-3 Months | No |