Endomicroscopy in Ulcerative Colitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
* Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Chromoscopy-guided endomicroscopy with targeted biopsies | Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes<br>* chromoscopy-guided endomicroscopy with targeted biopsies<br>* Other names: Endomicroscope;|
| Active Comparator: B<br>Standard endoscopy with random and targeted biopsies | Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes<br>* Standard endoscopy with random and targeted biopsies<br>* Other names: Endomicroscope;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to investigate whether chromoscopy-guided endomicroscopy has a higher sensitivity than standard endoscopy with respect to detection of IN and to compare the proportion of patients with at least one IN |  | Day 1 (colonoscopy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of chromoscopy-guided endomicroscopy in the detection of lesions and in the reduction of the number of biopsies. Time needed for the examination will be measured and compared between the two groups. |  | Day 1 (colonoscopy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Endomicroscopy, Chromoendoscopy, Confocal colonoscope, Surveillance colonoscopy