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
1 other identifier
interventional
152
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2015
CompletedAugust 20, 2019
August 1, 2019
3.4 years
April 1, 2014
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
number of lesions
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
Study Arms (2)
chromoendoscopy
OTHERHigh definition (HD) endoscopy
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnancy
- Unwilling or unable to give informed consent
- Severe active colitis (as assessed by the endoscopist)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS1 3EX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2014
First Posted
May 14, 2014
Study Start
May 1, 2012
Primary Completion
September 19, 2015
Study Completion
September 19, 2015
Last Updated
August 20, 2019
Record last verified: 2019-08