Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
Primary Purpose
Inflammatory Bowel Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual chromoendoscopy
Conventional chromoendoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Inflammatory Bowel Disease focused on measuring Colitis, Dysplasia, Chromoendoscopy
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
Sites / Locations
- King's College Hospital NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional chromoendoscopy
Virtual chromoendoscopy
Arm Description
Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray)
Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy
Outcomes
Primary Outcome Measures
Patient adherence to study design - success of recruitment (minimum recruitment of 75%) and retention of patients (minimum target of 75%)
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%
Secondary Outcome Measures
Patient experience assessed by validated questionnaire
Patient experience of the procedure in both arms will be compared (intra-individual) by validated questionnaire
Procedure time
The time taken for each procedure will be compared (average)
Miss rate for dysplasia
The miss rate of each technique will be compared
Prediction of histology
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)
Full Information
NCT ID
NCT02543021
First Posted
September 4, 2015
Last Updated
August 28, 2018
Sponsor
King's College Hospital NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT02543021
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
February 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College Hospital NHS Trust
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease
Keywords
Colitis, Dysplasia, Chromoendoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional chromoendoscopy
Arm Type
Active Comparator
Arm Description
Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray)
Arm Title
Virtual chromoendoscopy
Arm Type
Experimental
Arm Description
Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy
Intervention Type
Device
Intervention Name(s)
Virtual chromoendoscopy
Other Intervention Name(s)
Fujinon Intelligent Color Enhancement (FICE)
Intervention Description
Digital / virtual chromoendoscopy with FICE
Intervention Type
Procedure
Intervention Name(s)
Conventional chromoendoscopy
Other Intervention Name(s)
Indigo carmine dye spray
Intervention Description
Conventional chromoendoscopy with indigo carmine dye spray
Primary Outcome Measure Information:
Title
Patient adherence to study design - success of recruitment (minimum recruitment of 75%) and retention of patients (minimum target of 75%)
Description
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%
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient experience assessed by validated questionnaire
Description
Patient experience of the procedure in both arms will be compared (intra-individual) by validated questionnaire
Time Frame
2 years
Title
Procedure time
Description
The time taken for each procedure will be compared (average)
Time Frame
2 years
Title
Miss rate for dysplasia
Description
The miss rate of each technique will be compared
Time Frame
2 years
Title
Prediction of histology
Description
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)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bu'Hussain Hayee, FRCP
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patient level data will not be shared. Cohort results will form publication/output
Citations:
PubMed Identifier
36250171
Citation
Pavlidis P, Joshi D, El Sherif Y, Warner B, Gulati S, Alexander J, Cross G, Dew T, Arqoub HA, Devlin J, Heneghan M, Dubois P, Bjarnason I, Powell N, Hayee B. Faecal calprotectin is a surrogate marker of biliary inflammation in primary sclerosing cholangitis associated inflammatory bowel disease. Frontline Gastroenterol. 2022 Mar 18;13(6):497-502. doi: 10.1136/flgastro-2021-102053. eCollection 2022.
Results Reference
derived
Learn more about this trial
Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
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