Endomicroscopy in Ulcerative Colitis

Pentax Medical

Status

Terminated

Conditions

Ulcerative Colitis

Treatments

Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00659867

2006-09

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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