Endomicroscopy in Ulcerative Colitis - Full Text View

Purpose

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.

Condition	Intervention
Ulcerative Colitis	Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes

Genetics Home Reference related topics:

Crohn disease

MedlinePlus related topics:

Cancer Endoscopy Ulcerative Colitis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by PENTAX Europe GmbH:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	April 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Chromoscopy-guided endomicroscopy with targeted biopsies	Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes chromoscopy-guided endomicroscopy with targeted biopsies
B: Active Comparator Standard endoscopy with random and targeted biopsies	Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes Standard endoscopy with random and targeted biopsies

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659867

Contacts


Contact: Ralf Kiesslich, MD	49-613-117-7299	info@ralf-kiesslich.de

Locations


Germany
	Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik	Not yet recruiting
	Mainz, Germany, 55101
	Contact: Ralf Kiesslich, MD 49-613-117-7299 info@ralf-kiesslich.de
	Principal Investigator: Ralf Kiesslich, MD
	Sub-Investigator: Martin Götz, MD
	Charité Campus Benjamin Franklin, Medizinische Klinik I	Not yet recruiting
	Berlin, Germany, 12200
	Contact: Christian Bojarski, MD 49-308-445-2627 christian.bojarski@charite.de
	Principal Investigator: Martin Zeitz, MD
	Sub-Investigator: Christian Bojarski, MD

Italy
	Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division	Not yet recruiting
	Crema, Italy, 26013
	Contact: Alessandro Zambelli, MD 39-373-2803-20402 a.zambelli@hcrema.it
	Principal Investigator: Alessandro Zambelli, MD
	European Institute of Oncology, Division of Endoscopy	Not yet recruiting
	Milano, Italy, 20141
	Contact: Cristiano Crosta, MD 39-257-489-068 cristiano.crosta@ieo.it
	Principal Investigator: Cristiano Crosta, MD

United Kingdom, South Yorkshire
	Central Sheffield University Hospitals NHS Trust, Royal Hallamshire Hospital	Not yet recruiting
	Sheffield, South Yorkshire, United Kingdom, S10 2JF
	Contact: Paul Hurlstone, MD 44-114-271-2166 paul.hurlstone@sheffield.ac.uk
	Principal Investigator: Paul Hurlstone, MD

Sponsors and Collaborators

PENTAX Europe GmbH

Johannes Gutenberg University Mainz

Investigators


Principal Investigator:	Ralf Kiesslich, MD	Johannes Gutenberg-Universität Mainz, I. Med. Klinik

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Pentax Europe GmbH ( Jenny Adebahr )
Study ID Numbers:	2006-09
First Received:	April 14, 2008
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00659867
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Italy: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by PENTAX Europe GmbH:

Ulcerative Colitis

Endomicroscopy

Chromoendoscopy

Confocal colonoscope

Surveillance colonoscopy

Study placed in the following topic categories:

Digestive System Diseases

Gastrointestinal Diseases

Ulcer

Colonic Diseases

Inflammatory Bowel Diseases

Colitis, Ulcerative

Intestinal Diseases

Gastroenteritis

Colitis

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	PENTAX Europe GmbH Johannes Gutenberg University Mainz
Information provided by:	PENTAX Europe GmbH
ClinicalTrials.gov Identifier:	NCT00659867