Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

Phase 4

Completed

• Conditions: Crohn Disease Located in Jejunum or Ileum
• Interventions: Procedure: enteroscopy

• Registration Number: NCT01180452
• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-08-11
• Study First Posted: 2010-08-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single group open label	enteroscopy	Prospective Cohort

Primary Outcome Measures

Name	Time	Method
Frequency of dysplasia and adenocarcinoma	2 months	dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists

Secondary Outcome Measures

Name	Time	Method
Success of endoscopic detection	1-3 Months	the success will be measured by reaching at least one pathologic area during the endoscopic procedure

Trial Locations

Locations (15)

Chu Amiens; 🇫🇷 Amiens, France

Hopital Beaujon; 🇫🇷 Clichy, France

Chru Lille; 🇫🇷 Lille, France

CHU NICE; 🇫🇷 Nice, France

Hopital Saint Louis; 🇫🇷 Paris, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

CHU LYON; 🇫🇷 Pierre Benite, France

Institut Mutualiste Montsouris (Imm); 🇫🇷 Paris, France

Chu Rouen; 🇫🇷 Rouen, France

Chu Saint Etienne; 🇫🇷 St Etienne, France

Chu Tours; 🇫🇷 Tours, France

Chu Toulouse; 🇫🇷 Toulouse, France

Chu Nancy; 🇫🇷 Vandoeuvre Les Nancy, France

Chu Besancon; 🇫🇷 Besancon, France

Hopital Bicetre; 🇫🇷 Le Kremlin Bicetre, France