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

NCT00816491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-06-01

No results posted yet for this study

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

Interventions

DEVICE

conventional white light colonoscopy

conventional white light colonoscopy

DEVICE

FICE (Fujinon Intelligent Chromoendoscopy)

chromoendoscopy

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nice

    lead OTHER

Principal Investigators

  • Geoffrey VANBIERVLIET, PH · Departement d'Endoscopie digestive, CHU de Nice

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2011-09-26
Completion
2013-11-09

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00816491 on ClinicalTrials.gov