Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

Tracking Information
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; (submitted: September 4, 2015)	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%
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02543021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 4, 2015)	Patient experience assessed by validated questionnaire [ Time Frame: 2 years ]Patient experience of the procedure in both arms will be compared (intra-individual) by validated questionnaire; Procedure time [ Time Frame: 2 years ]The time taken for each procedure will be compared (average); Miss rate for dysplasia [ Time Frame: 2 years ]The miss rate of each technique will be compared; Prediction of histology [ Time Frame: 2 years ]The ability of conventional vs virtual chromoendoscopy will be compared to predict eventual histology of targeted biopsies (from which a sensitivity and specificity will be calculated)
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Inflammatory Bowel Disease
Intervention ICMJE	Device: Virtual chromoendoscopy Digital / virtual chromoendoscopy with FICE Other Name: Fujinon Intelligent Color Enhancement (FICE); Procedure: Conventional chromoendoscopy Conventional chromoendoscopy with indigo carmine dye spray Other Name: Indigo carmine dye spray
Study Arms	Active Comparator: Conventional chromoendoscopy Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray) Intervention: Procedure: Conventional chromoendoscopy; Experimental: Virtual chromoendoscopy Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy Intervention: Device: Virtual chromoendoscopy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: September 4, 2015)	60
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	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: Ulcerative pan-proctocolitis or Crohn's colitis of 8 or more years duration; With or without co-diagnosis of primary sclerosing cholangitis Exclusion Criteria: Inability to provide informed; Written consent
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 75 Years (Adult, Older Adult)
Accepts Healthy Volunteers	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	Plan to Share IPD: No Plan Description: Patient level data will not be shared. Cohort results will form publication/output
Responsible Party	King's College Hospital NHS Trust
Study Sponsor ICMJE	King's College Hospital NHS Trust
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Bu'Hussain Hayee, FRCP King's College Hospital NHS Trust
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