Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
Condition: Inflammatory Bowel Disease
MeSH terms: Colitis; Inflammatory Bowel Diseases
Study type: Interventional

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.
    

Intervention name(s): Virtual chromoendoscopy; Conventional chromoendoscopy
Intervention type(s): Device; Procedure
Intervention description(s): Digital / virtual chromoendoscopy with FICE; Conventional chromoendoscopy with indigo carmine dye spray
Other intervention name(s): Fujinon Intelligent Color Enhancement (FICE); Indigo carmine dye spray
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colitis; Dysplasia; Chromoendoscopy