Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

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

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
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 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.

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  ICMJE 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  ICMJE
  • 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  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:

  • 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  ICMJE
Sexes Eligible for Study: All
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
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