Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

• ClinicalTrials.gov Identifier: NCT02543021
• Recruitment Status: Completed
• First Posted: September 7, 2015
• Last Update Posted: August 31, 2018
• Sponsor: King's College Hospital NHS Trust
• Information provided by (Responsible Party): King's College Hospital NHS Trust

Tracking Information

• First Submitted Date: September 4, 2015
• First Posted Date: September 7, 2015
• Last Update Posted Date: August 31, 2018
• Actual Study Start Date: November 1, 2015
• Actual Primary Completion Date: November 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Inflammatory Bowel Disease

Intervention

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 4, 2015): 60
• Original Estimated Enrollment: 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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT02543021
• Other Study ID Numbers: 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

• Current Responsible Party: King's College Hospital NHS Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: King's College Hospital NHS Trust
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bu'Hussain Hayee, FRCP; King's College Hospital NHS Trust

• PRS Account: King's College Hospital NHS Trust
• Verification Date: August 2018