Status:
COMPLETED
Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia
Lead Sponsor:
Johannes Gutenberg University Mainz
Conditions:
Ulcerative Colitis
Intraepithelial Neoplasia
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomic...
Detailed Description
Ulcerative colitis (UC) is an immune cell-mediated inflammatory bowel disease characterized by mucosal ulcerations, rectal bleeding, diarrhea, and abdominal pain. Patients with long standing UC face a...
Eligibility Criteria
Inclusion
- Clinically and histologically verified UC
- Disease duration \>8 years
- Colitis Activity Index ≤8
- Activity index of Truelove and Witts: mild
Exclusion
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time \<50% of control, Partial thromboplastin time \>50 s)
- Impaired renal function (Creatinine \>1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
- Known allergy to methylene blue or Fluorescein
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
November 1 2004
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00352404
Start Date
August 1 2003
End Date
November 1 2004
Last Update
July 14 2006
Active Locations (1)
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1
I. Med. Klinik, Johannes Gutenberg Universitaet
Mainz, Rhineland-Palatinate, Germany, 55131