CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 107 enrolled
Drug / intervention
enteroscopyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01180452
NCT01180452Phase 4Completed

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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives·interventional·Posted Aug 12, 2010·Updated Jun 23, 2015

In Brief

A Phase 4 clinical trial evaluating enteroscopy for Crohn Disease Located in Jejunum or Ileum. Completed, enrolled 107 participants across 15 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 12, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.9 years ago

Interventions

enteroscopyprocedure

endoscopic enteroscopy to do biopsies on jejunum