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High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
High definition (HD) endoscopy
chromoendoscopy
Sponsored by
The Leeds Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

chromoendoscopy

High definition (HD) endoscopy

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2014
Last Updated
August 16, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02138318
Brief Title
High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)
Official Title
Randomized Controlled Trial of High Definition White Light Endoscopy Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2012 (Actual)
Primary Completion Date
September 19, 2015 (Actual)
Study Completion Date
September 19, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chromoendoscopy
Arm Type
Other
Arm Title
High definition (HD) endoscopy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
High definition (HD) endoscopy
Intervention Type
Other
Intervention Name(s)
chromoendoscopy
Primary Outcome Measure Information:
Title
number of lesions
Description
The number of lesions with at least low grade dysplasia detected by targeted biopsy to be compared between the two groups by chisquared test.
Time Frame
Once annually at routine clinical assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS1 3EX
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)

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