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Endomicroscopy in Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT00659867
Recruitment Status : Terminated (Recruitment problems)
First Posted : April 16, 2008
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Annette Weissmann, PENTAX Europe GmbH

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Device: PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : December 2008
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Keywords provided by Annette Weissmann, 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