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Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01180452
Acronym
DYDJI
Enrollment
107
Registered
2010-08-12
Start date
2010-01-31
Completion date
2014-06-30
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease Located in Jejunum or Ileum

Keywords

Crohn disease, dysplasia, adenocarcinoma, endoscopy, jejunum, ileum

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

Interventions

PROCEDUREenteroscopy

endoscopic enteroscopy to do biopsies on jejunum

Sponsors

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of dysplasia and adenocarcinoma2 monthsdysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists

Secondary

MeasureTime frameDescription
Success of endoscopic detection1-3 Monthsthe success will be measured by reaching at least one pathologic area during the endoscopic procedure

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026