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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138318
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
The Leeds Teaching Hospitals NHS Trust

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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: High definition (HD) endoscopy Other: chromoendoscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of High Definition White Light Endoscopy Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis Surveillance
Actual Study Start Date : May 1, 2012
Actual Primary Completion Date : September 19, 2015
Actual Study Completion Date : September 19, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
chromoendoscopy Other: chromoendoscopy
High definition (HD) endoscopy Other: High definition (HD) endoscopy



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138318


Locations
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United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom, LS1 3EX
Sponsors and Collaborators
The Leeds Teaching Hospitals NHS Trust
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Responsible Party: The Leeds Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02138318    
Other Study ID Numbers: GA12/10210
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases