- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138318
High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)
Randomized Controlled Trial of High Definition White Light Endoscopy Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance
Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC) compared to the general population. Regular screening by colonoscopy is an internationally recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon has been the mainstay of conventional surveillance practice to detect abnormalities, known as dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and processed, a practice which is is tedious, expensive, time consuming and has a low pickup rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard conventional white light colonoscopy (WLC).
Detection can be improved by the application of dyes which highlight more subtle abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia detection but more time consuming for the patient and cannot guarantee that the whole colon is covered. CE has only been compared in clinical trials with standard definition endoscopy rather than the recently available high definition endoscopes with better resolution and picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution CCD (charge coupled device) providing much better images than standard video endoscopy. HD colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the need for the extra time and experience required for dye spraying for both endoscopists and nursing staff.
The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for ulcerative colitis. There have been no trials comparing these two modalities and the investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy would be marginal and therefore CE would be reserved for procedures using standard definition scopes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Yorkshire
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Leeds, West Yorkshire, United Kingdom, LS1 3EX
- Leeds Teaching Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with longstanding (more than 10 years), extensive (extending proximal to the splenic flexure) colitis attending for surveillance colonoscopy.
- Patients over 18 years of age
Exclusion Criteria:
- Pregnancy
- Unwilling or unable to give informed consent
- Severe active colitis (as assessed by the endoscopist)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: chromoendoscopy
|
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Other: High definition (HD) endoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of lesions
Time Frame: Once annually at routine clinical assessment
|
The number of lesions with at least low grade dysplasia detected by targeted biopsy to be compared between the two groups by chisquared test.
|
Once annually at routine clinical assessment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GA12/10210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ulcerative Colitis
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-
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-
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-
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-
Immune PharmaceuticalsUnknownUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateIsrael
Clinical Trials on chromoendoscopy
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Portsmouth Hospitals NHS TrustCompletedUlcerative Colitis | Crohn's ColitisUnited Kingdom
-
Indiana University School of MedicineCompletedCrohn's Disease | Ulcerative ColitisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedUlcerative Colitis | ChromoendoscopyNetherlands
-
King's College Hospital NHS TrustCompletedInflammatory Bowel DiseaseUnited Kingdom
-
VA Northern California Health Care SystemCompleted
-
Mayo ClinicCompletedColonic PolypsUnited States
-
Universitaire Ziekenhuizen KU LeuvenMcGill University; Maastricht University Medical Center; Copenhagen University... and other collaboratorsUnknownUlcerative ColitisBelgium, Canada, Denmark, Netherlands
-
Shandong UniversityTongji Hospital; Wuhan Union Hospital, China; Zhejiang UniversityUnknownDiagnostic Yield of Gastric NeoplasiaChina
-
KU LeuvenRecruitingDysplasia in Longstanding Achalasia | Relation Between Food Stasis and DysplasiaBelgium
-
Centre Hospitalier Universitaire de NiceCompleted