Endomicroscopy in Ulcerative Colitis

Chromoscopy-guided Endomicroscopy With the PENTAX EC-3870CIFK / EC-3870CILK Confocal Colonoscopes for the Detection of Intraepithelial Neoplasias in Subjects With Long Standing Ulcerative Colitis

This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy. The patients are examined with the PENTAX EC-3870CIFK and EC-3870CILK confocal colonoscopes either by chromoscopy-guided endomicroscopy with targeted biopsies or by standard endoscopy with random and targeted biopsies. The aim is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of intraepithelial neoplasia (IN) and to compare the proportion of patients with at least 1 IN detected by chromoscopy-guided endomicroscopy versus standard endoscopy.

Inclusion Criteria:

• Written informed consent must be available before any trial-related procedures
• Male and female patients aged 18 years and older
• Clinically and histologically verified UC
• Duration or Colitis ulcerosa >8 years (date of first diagnosis)
• Colitis Activity Index ≤ 8
• Activity index of Truelove and Witts: mild
• Ability of subject to understand character and individual consequences of clinical trial
• For women with childbearing potential, adequate contraception.

Exclusion Criteria:

• 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
• Active GI Bleeding
• Known allergy to methylene blue or fluorescein
• Participation in other clinical trials within the last 4 weeks