Endomicroscopy in Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-09-30

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.

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Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Chromoscopy-guided endomicroscopy with targeted biopsies

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

chromoscopy-guided endomicroscopy with targeted biopsies

B

Standard endoscopy with random and targeted biopsies

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

Standard endoscopy with random and targeted biopsies

Interventions

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

chromoscopy-guided endomicroscopy with targeted biopsies

Intervention Type DEVICE

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

Standard endoscopy with random and targeted biopsies

Intervention Type DEVICE

Other Intervention Names

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Endomicroscope Endomicroscope

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No