Endomicroscopy in Ulcerative Colitis

PENTAX Europe GmbH182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

182

Conditions

Ulcerative Colitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

Charité Campus Benjamin Franklin, Medizinische Klinik I

Berlin, Germany

Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II

Jena, Germany

Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik

Mainz, Germany

Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division

Crema, Italy

European Institute of Oncology, Division of Endoscopy

Milan, Italy

Outcomes

Primary Outcomes

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

Time frame: Day 1 (colonoscopy)

Secondary Outcomes

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.

Time frame: Day 1 (colonoscopy)