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Comparison Between Chromoendoscopy and Conventional Colonoscopy to Improve the Detection of Neoplasia in Patients With Ulcerative Colitis (UC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816491
First Posted: January 1, 2009
Last Update Posted: January 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Nice
  Purpose
The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random biopsies) in the endoscopic surveillance of patient with long-standing UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using each technique. The combined histological outcome following the two procedures will represent the gold-standard diagnosis for each patient. Secondary outcomes will be the number of patients with false-positive findings, the number of neoplastic lesions detected, the number of false-positive lesions per patient for each technique and the total time required for each procedure.

Condition Intervention
Ulcerative Colitis Device: conventional white light colonoscopy Device: FICE (Fujinon Intelligent Chromoendoscopy)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparaison de la Chromo Endoscopie Virtuelle FICE (Fujinon Intelligent Chromoendoscopy) Avec la Coloscopie Conventionnelle Dans la détection de la Dysplasie Chez Patients Porteurs de Recto Colite ulcéro hémorragique (RCH).

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy) [ Time Frame: 3 months between FICE and Conventional white light colonoscopy ]

Secondary Outcome Measures:
  • The goal is to detect more and earlier neoplastic lesions in order to influence patient management in terms of treatment (potential colectomy) and surveillance. [ Time Frame: 3 months between FICE and Conventional white light colonoscopy ]
  • To quantify the number of true positive and false positive lesions by comparing the number of targeted biopsies performed for suspicious lesions and the resulting histological findings. [ Time Frame: 3 months between FICE and Conventional white light colonoscopy ]

Estimated Enrollment: 80
Study Start Date: October 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Conventional white light colonoscopy
Device: conventional white light colonoscopy
conventional white light colonoscopy
Experimental: B
Chromoendoscopy
Device: FICE (Fujinon Intelligent Chromoendoscopy)
chromoendoscopy

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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:

  • Clinically and histologically verified UC
  • Disease duration ≥ 8 years
  • A Mayo score ≤ 8 with an endoscopic sub score ≤ 2
  • CPAM affiliation
  • Able to give written informed consent to participate in the study

Exclusion Criteria:

  • Known intraepithelial neoplasia or colorectal cancer or any other active malignancy
  • Previous colo-rectal surgery
  • Non-treatable coagulopathy or hemostatic dysfunction (prothrombin index < 50% of control or/and partial thromboplastin time > 50 seconds and/or thrombopenia < 60000 / mm3)
  • Pregnancy
  • Inability to give informed consent
  Contacts and Locations
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): NCT00816491


Contacts
Contact: Geoffrey VANBIERVLIET, PH vanbiervliet.g@chu-nice.fr

Locations
France
Departement d'Endoscopie digestive - Hopital Archet 2, CHU de Nice Recruiting
Nice, France, 06202
Contact: Cynthia GIRAN    0492034589    giran.c@chu-nice.fr   
Contact: Djedjiga NAUDIN    0492035481    naudin.d@chu-nice.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Geoffrey VANBIERVLIET, PH Departement d'Endoscopie digestive, CHU de Nice
  More Information

Responsible Party: Departement de la Recherche Clinique et de l'Innovation, CHU de Nice
ClinicalTrials.gov Identifier: NCT00816491     History of Changes
Other Study ID Numbers: 08-PP-06
First Submitted: December 31, 2008
First Posted: January 1, 2009
Last Update Posted: January 16, 2009
Last Verified: January 2009

Keywords provided by Centre Hospitalier Universitaire de Nice:
patient with long-standing UC

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