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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 because the information has not been verified recently.
Verified January 2009 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00816491
First received: December 31, 2008
Last updated: January 15, 2009
Last verified: January 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 31, 2008
Last Updated: January 15, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 19, 2013