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NCT Number: NCT01180452

Endoscopic Detection of Dysplasia in Crohn 's Disease Patient

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

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Key information

Conditions

Crohn Disease Located in Jejunum or Ileum Adenocarcinoma Carcinoma Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chu Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

enteroscopy

Procedure

endoscopic enteroscopy to do biopsies on jejunum

Primary outcomes

  1. Frequency of dysplasia and adenocarcinoma

    Time frame: 2 months

    dysplasia will be described as high or low level Samples will be analysed by 2 different team of anapathologists

Secondary outcomes

  1. Success of endoscopic detection

    Time frame: 1-3 Months

    the success will be measured by reaching at least one pathologic area during the endoscopic procedure

Sponsors and collaborators

Lead sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Other

Registry information

Official study 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

Acronym: DYDJI

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Aug 12, 2010
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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