Clinical trial NCT00659867: Endomicroscopy in Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Endomicroscopy
Chromoendoscopy
Confocal colonoscope
Surveillance colonoscopy
Lead sponsor: PENTAX Europe GmbH
Sponsor class: INDUSTRY
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2008-04-16
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Day 1 (colonoscopy)
Secondary outcomes:
measure: 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.
timeFrame: Day 1 (colonoscopy)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Benjamin Franklin, Medizinische Klinik I
city: Jena
country: Germany
facility: Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
city: Crema
country: Italy
facility: Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
city: Milano
country: Italy
facility: European Institute of Oncology, Division of Endoscopy
Study officials:
affiliation: Johannes Gutenberg-Universität Mainz, I. Med. Klinik
name: Ralf Kiesslich, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hurlstone DP, Kiesslich R, Thomson M, Atkinson R, Cross SS. Confocal chromoscopic endomicroscopy is superior to chromoscopy alone for the detection and characterisation of intraepithelial neoplasia in chronic ulcerative colitis. Gut. 2008 Feb;57(2):196-204. doi: 10.1136/gut.2007.131359.