Inflammatory Bowel DiseaseNCT02543021
Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study
A study testing Virtual chromoendoscopy and Conventional chromoendoscopy in people with Inflammatory Bowel Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- Virtual chromoendoscopy and Conventional chromoendoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2015to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to provide informed
- Written consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital NHS Foundation Trust
London, SE5 9RS
About this 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
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.
Read more
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.
Read the 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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- Virtual chromoendoscopy, Conventional chromoendoscopy
- Keywords
- Colitis, Dysplasia, Chromoendoscopy
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual chromoendoscopyDevice
Also called Fujinon Intelligent Color Enhancement (FICE)
Digital / virtual chromoendoscopy with FICE
Conventional chromoendoscopyProcedure or surgery
Also called Indigo carmine dye spray
Conventional chromoendoscopy with indigo carmine dye spray
| Study group | Role | What they receive |
|---|---|---|
| Conventional chromoendoscopy | Active comparator | Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray) Receives: Procedure: Conventional chromoendoscopy |
| Virtual chromoendoscopy | Experimental | Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy Receives: Device: Virtual chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 2 years
Secondary outcomes (4)
Patient experience assessed by validated questionnaire
Patient experience of the procedure in both arms will be compared (intra-individual) by validated questionnaire
Measured: 2 years
Procedure time
The time taken for each procedure will be compared (average)
Measured: 2 years
Miss rate for dysplasia
The miss rate of each technique will be compared
Measured: 2 years
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)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start1 Nov 2015
- Primary completion1 Nov 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bu'Hussain Hayee, FRCP, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543021
- Sponsor's protocol ID
- 113398
- Status last verified
- Aug 2018
- First submitted
- 4 Sep 2015
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Patient level data will not be shared. Cohort results will form publication/output
Publications
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.
PubMed 36250171
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02543021
- Acronym / sponsor ID
- 113398
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Colitis, Dysplasia, Chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 7 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional chromoendoscopy | Active comparator | Procedure: Conventional chromoendoscopyPatients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray) |
| Virtual chromoendoscopy | Experimental | Device: Virtual chromoendoscopyPatients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to provide informed
- Written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual chromoendoscopyAlso: Fujinon Intelligent Color Enhancement (FICE)Digital / virtual chromoendoscopy with FICE | Device | Virtual chromoendoscopy |
| Conventional chromoendoscopyAlso: Indigo carmine dye sprayConventional chromoendoscopy with indigo carmine dye spray | Procedure or surgery | Conventional chromoendoscopy |
Primary outcome
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%
4 secondary outcomes
Patient experience assessed by validated questionnaire
Time frame: 2 years
Procedure time
Time frame: 2 years
Miss rate for dysplasia
Time frame: 2 years
Prediction of histology
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Derived from this study: PubMed 36250171Pavlidis 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.
- Individual participant dataSharing planned: No. Patient level data will not be shared. Cohort results will form publication/output
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bu'Hussain Hayee, FRCP principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual chromoendoscopy and Conventional chromoendoscopy in people with Inflammatory Bowel Disease, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient adherence to study design - success of recruitment (minimum recruitment of 75%) and retention of patients (minimum target of 75%) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02543021, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.