Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
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ClinicalTrials.gov Identifier: NCT02543021 |
Recruitment Status :
Completed
First Posted : September 7, 2015
Last Update Posted : August 31, 2018
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Tracking Information | |||||
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First Submitted Date ICMJE | September 4, 2015 | ||||
First Posted Date ICMJE | September 7, 2015 | ||||
Last Update Posted Date | August 31, 2018 | ||||
Actual Study Start Date ICMJE | November 1, 2015 | ||||
Actual Primary Completion Date | November 1, 2017 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Patient adherence to study design - success of recruitment (minimum recruitment of 75%) and retention of patients (minimum target of 75%) [ Time Frame: 2 years ] The investigators are evaluating the success of recruitment to the study design with a target minimum recruitment of 75%; The investigators will also evaluate retention of patients within the crossover study design with a minimum target of 75%
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study | ||||
Official Title ICMJE | A Study to Assess the Feasibility and Patient Acceptability of a Randomised, Crossover Design to Compare Virtual vs Conventional Chromoendoscopy for the Detection of Dysplasia in Colitis | ||||
Brief Summary | Patients with colitis require regular 'surveillance' colonoscopy as their risk of developing colon cancer is at least 2.5 times that of the general population. However, cancer in colitis develops as flat lesions called dysplasia, that can be easily missed at routine colonoscopy. As a result NICE guidelines for colitis surveillance recommend the use of a technique called chromoendoscopy (CE) in which a water-soluble blue dye is sprayed through the colonoscope to coat and highlight the lining of the bowel, making dysplasia easier to see. Although CE is accepted as best practice for surveillance it is time-consuming, technically difficult and requires expertise to interpret the appearances. For these reasons, its use is not widespread and the vast majority of patients still receive the inferior 'routine' colonoscopy without CE. New technology means that the video image obtained during colonoscopy can be digitally enhanced and coloured at the press of a button - termed virtual chromoendoscopy (VCE). This could make surveillance colonoscopy shorter, more comfortable and cleaner (resulting in a more 'dignified' experience) as well as cheaper and less technically difficult. The main objectives to be explored in this feasibility study (and the larger trial) were informed by a PPI meeting, which placed the ability to detect dysplasia at equal importance with the participant's experience of the procedure in terms of speed, comfort and dignity. This is primarily a feasibility study to assess patient experience, recruitment and retention rates to the investigators' specified trial design, to support the development of a larger crossover trial to compare VCE to CE during surveillance colonoscopy for colitis. |
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Detailed Description | In the recruitment period, 60 patients will be approached when they are invited to attend for scheduled surveillance colonoscopy. Eligible patients (18-75 yrs) who agree to participate will be randomised to undergo CE or VCE as the first procedure. Data will be captured by an Observer using a bespoke Access-based program. The site and number of any biopsy samples taken will be recorded alongside the Endoscopist's prediction, based on visual appearance, of whether they think the area biopsied is actually dysplasia. After an agreed interval (no more than 8 weeks, usually 3-6), participants will undergo a second colonoscopy with the second technique, performed by an Endoscopist blinded to the results of the first test, and data captured as before. For each procedure, a questionnaire assessing immediate patient experience will be administered in the Endoscopy department, after the participant has recovered from the procedure. Participants will also be given a second questionnaire assessing their overall experience to take home and complete 48 hours after the procedure, which will be returned by post. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
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Condition ICMJE | Inflammatory Bowel Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
60 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | February 1, 2018 | ||||
Actual Primary Completion Date | November 1, 2017 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Any patient eligible for colitis surveillance colonoscopy by British Society of Gastroenterology guidelines:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United Kingdom | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02543021 | ||||
Other Study ID Numbers ICMJE | 113398 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Current Responsible Party | King's College Hospital NHS Trust | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | King's College Hospital NHS Trust | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | King's College Hospital NHS Trust | ||||
Verification Date | August 2018 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |