Status:
COMPLETED
Comparison Between Chromoendoscopy and Conventional Colonoscopy to Improve the Detection of Neoplasia in Patients With Ulcerative Colitis (UC)
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random bi...
Detailed Description
Patients will undergo two colonoscopies each, with an interval of three months between procedures. This minimum time interval is chosen in order to allow for the healing of the mucosa on sampled areas...
Eligibility Criteria
Inclusion
- Clinically and histologically verified UC
- Disease duration ≥ 8 years
- A Mayo score ≤ 8 with an endoscopic sub score ≤ 2
- CPAM affiliation
- Able to give written informed consent to participate in the study
Exclusion
- Known intraepithelial neoplasia or colorectal cancer or any other active malignancy
- Previous colo-rectal surgery
- Non-treatable coagulopathy or hemostatic dysfunction (prothrombin index \< 50% of control or/and partial thromboplastin time \> 50 seconds and/or thrombopenia \< 60000 / mm3)
- Pregnancy
- Inability to give informed consent
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00816491
Start Date
October 1 2008
End Date
November 9 2013
Last Update
June 1 2022
Active Locations (1)
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1
Departement d'Endoscopie digestive - Hopital Archet 2, CHU de Nice
Nice, France, 06202