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

NCT00816491 | Completed

• 1 other identifier: 08-PP-06
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

patient with long-standing UC

Outcome Measures

Primary Outcomes (1)

• 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)

  3 months between FICE and Conventional white light colonoscopy

Secondary Outcomes (2)

• The goal is to detect more and earlier neoplastic lesions in order to influence patient management in terms of treatment (potential colectomy) and surveillance.

  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.

  3 months between FICE and Conventional white light colonoscopy

Study Arms (2)

A

ACTIVE COMPARATOR

Conventional white light colonoscopy

Device: conventional white light colonoscopy

B

EXPERIMENTAL

Chromoendoscopy

Device: FICE (Fujinon Intelligent Chromoendoscopy)

Interventions

conventional white light colonoscopy DEVICE

conventional white light colonoscopy

A

FICE (Fujinon Intelligent Chromoendoscopy) DEVICE

chromoendoscopy

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

Departement d'Endoscopie digestive - Hopital Archet 2, CHU de Nice

Nice, 06202, France

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Geoffrey VANBIERVLIET, PH

  Departement d'Endoscopie digestive, CHU de Nice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 1, 2009
• Study Start: October 1, 2008
• Primary Completion: September 26, 2011
• Study Completion: November 9, 2013
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

FR (1)