Endoscopic Detection of Dysplasia in Crohn 's Disease Patient (DYDJI)

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Completed; Phase 4

Conditions: Crohn Disease Located in Jejunum or Ileum

Treatments: Procedure: enteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01180452

GETAID 2008-4

Details and patient eligibility

About

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

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

Single group open label

Other group

Description:

Prospective Cohort

Treatment:

Procedure: enteroscopy