Endomicroscopy in Ulcerative Colitis

This study has been terminated.
(Recruitment problems)
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Annette Weissmann, PENTAX Europe GmbH
ClinicalTrials.gov Identifier:
NCT00659867
First received: April 14, 2008
Last updated: March 12, 2014
Last verified: March 2014
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


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 ]

Enrollment: 182
Study Start Date: December 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Chromoscopy-guided endomicroscopy with targeted biopsies
Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
chromoscopy-guided endomicroscopy with targeted biopsies
Other Name: Endomicroscope
Active Comparator: B
Standard endoscopy with random and targeted biopsies
Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
Standard endoscopy with random and targeted biopsies
Other Name: Endomicroscope

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Charité Campus Benjamin Franklin, Medizinische Klinik I
Berlin, Germany, 12200
Friedrich-Schiller-Universität Jena, Klinik für Innere Medizin II
Jena, Germany, 07740
Johannes Gutenberg-Universität Mainz, I. Med. Klinik und Poliklinik
Mainz, Germany, 55101
Italy
Ospedale Maggiore di Crema, Endoscopy and Gastroenterology Division
Crema, Italy, 26013
European Institute of Oncology, Division of Endoscopy
Milano, Italy, 20141
Sponsors and Collaborators
PENTAX Europe GmbH
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Ralf Kiesslich, Prof. Dr. Johannes Gutenberg-Universität Mainz, I. Med. Klinik
  More Information

Additional Information:
Publications:
Responsible Party: Annette Weissmann, Trial Coordinator, PENTAX Europe GmbH
ClinicalTrials.gov Identifier: NCT00659867     History of Changes
Other Study ID Numbers: 2006-09
Study First Received: April 14, 2008
Last Updated: March 12, 2014
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

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases

ClinicalTrials.gov processed this record on October 19, 2014