Ulcerative ColitisVIRTUOSONCT02822352
RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis
A study testing Chromoendoscopy in people with Ulcerative Colitis and Crohn's Colitis, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Colitis is inflammation of the large bowel and it is often caused by conditions known as ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated inflammatory response against the bowel - the body attacks the bowel. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Crohn's Colitis
- What is being tested?
- Chromoendoscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2016to 7 Aug 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ulcerative Colitis or Crohn's colitis with a disease duration of >8 years for pancolitis or >15 years duration for left-sided colitis
- Aged 18 years and above
- Patients able to give informed consent
Who cannot join
- Persistent coagulopathy or platelet count <50x1012 which may preclude mucosal biopsy
- Known colonic IN or CRC
- Fulminant colitis
- Patients who have been previously randomised and withdrawn on 2 occasions due to poor bowel preparation
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: A Comparison Of High Definition White Light And High Definition Virtual Chromoendoscopy For The Detection Of Intraepithelial Neoplasia In Longstanding Colitis: A Randomised Controlled Trial
Colitis is inflammation of the large bowel and it is often caused by conditions known as ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated inflammatory response against the bowel - the body attacks the bowel. Patients who have had colitis affecting most of the large bowel for more than 8 years are at increased risk of cancer of the large bowel. In view of this, many national gastroenterology organisations have recommended that such patients have regular colonoscopies to detect pre-cancerous areas and even early cancer in the large bowel. Early detection of such areas, will lead to early treatment thereby reducing the risk of developing significant large bowel cancer. These regular colonoscopies are known as surveillance colonoscopies.
Official international guidelines for surveillance in patients with ulcerative and Crohn's colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters and of any suspicious areas. Recent studies have shown that spraying dye such as indigo carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous cells. This technique is time-consuming, and tedious. There are no set standards of what is considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an alternative method to improve the detection of pre-cancerous tissue in patients with longstanding colitis.
Read the detailed description
Virtual chromoendoscopy systems enhances specific characteristics of the lining of the large bowel such as surface patterns and mucosal vasculature. This theoretically increases the detection of pre-cancerous tissue compared to high definition white light endoscopy alone. Narrow-band imaging or NBI (Olympus, Tokyo, Japan), Blue Laser (Fujinon, Tokyo, Japan) and OE scan (Pentax, Tokyo, Japan) use optical light filters to select particular narrow spectrums of red, green and blue light with a relative decrease in the proportion of red light. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-SCAN system also allows post hoc modification of the images. It provides the ability to enhance the mucosal surface to better highlight mucosal changes.
These new imaging techniques have a theoretical advantage, which is extendedly used for sales purposes but so far has not been proven in the surveillance for precancerous or early cancer of the large bowel in patients with longstanding colitis.
- Conditions
- Ulcerative Colitis, Crohn's Colitis
- Being tested
- Chromoendoscopy
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromoendoscopyOther
High definition virtual chromoendoscopy
| Study group | Role | What they receive |
|---|---|---|
| High Definition White Light | No intervention | Surveillance colonoscopy using High Definition White Light alone |
| High Definition Virtualchromoendoscopy | Active comparator | High Definition Virtualchromoendoscopy Receives: Other: Chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy
Measured: 14 months
Secondary outcomes (2)
To assess the neoplasia detection rate in targeted biopsies versus non-targeted (segmental) biopsies within each arm of the study
The above is assessed by comparing the mean neoplasia per patient detection rate between virtual chromoendoscopy and high definition white light endoscopy as well as by assessing the yield of non-targeted quadratic biopsies in detecting neoplasia
Measured: 14 months
To compare the duration of time taken using each technique
This is measured by assessing the total withdrawal time taken in each arm of the study
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startAug 2016
- Primary completion8 Mar 2018
- Study completion7 Aug 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 Ulcerative ColitisStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822352
- Sponsor's protocol ID
- PHT/2016/02
- Acronym
- VIRTUOSO
- Status last verified
- Jan 2019
- First submitted
- 29 Jun 2016
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kandiah K, Subramaniam S, Thayalasekaran S, Chedgy FJ, Longcroft-Wheaton G, Fogg C, Brown JF, Smith SC, Iacucci M, Bhandari P. Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial). Gut. 2021 Sep;70(9):1684-1690. doi: 10.1136/gutjnl-2020-320980. Epub 2020 Nov 19.
PubMed 33214162
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Of High Definition White Light And High Definition Virtual Chromoendoscopy For The Detection Of Intraepithelial Neoplasia In Longstanding Colitis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02822352
- Acronym / sponsor ID
- VIRTUOSO / PHT/2016/02
- Conditions
- Ulcerative Colitis, Crohn's Colitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- Aug 2016
- Primary completion
- 8 Mar 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 4 Jul 2016 (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.
Colitis is inflammation of the large bowel and it is often caused by conditions known as ulcerative colitis and Crohn's disease. In these conditions, the body has an exaggerated inflammatory response against the bowel - the body attacks the bowel. Patients who have had colitis affecting most of the large bowel for more than 8 years are at increased risk of cancer of the large bowel. In view of this, many national gastroenterology organisations have recommended that such patients have regular colonoscopies to detect pre-cancerous areas and even early cancer in the large bowel. Early detection of such areas, will lead to early treatment thereby reducing the risk of developing significant large bowel cancer. These regular colonoscopies are known as surveillance colonoscopies.
Official international guidelines for surveillance in patients with ulcerative and Crohn's colitis advise to take 4 random samples of large bowel tissue (biopsies) every 10 centimeters and of any suspicious areas. Recent studies have shown that spraying dye such as indigo carmine (a type of food dye) helps highlight abnormal areas that could harbor pre-cancerous cells. This technique is time-consuming, and tedious. There are no set standards of what is considered a satisfactorily completed dye spray colonoscopy. The uptake of this technique in the UK has not been uniform. Therefore virtual chromoendoscopy has been studied as an alternative method to improve the detection of pre-cancerous tissue in patients with longstanding colitis.
Detailed description
Virtual chromoendoscopy systems enhances specific characteristics of the lining of the large bowel such as surface patterns and mucosal vasculature. This theoretically increases the detection of pre-cancerous tissue compared to high definition white light endoscopy alone. Narrow-band imaging or NBI (Olympus, Tokyo, Japan), Blue Laser (Fujinon, Tokyo, Japan) and OE scan (Pentax, Tokyo, Japan) use optical light filters to select particular narrow spectrums of red, green and blue light with a relative decrease in the proportion of red light. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-SCAN system also allows post hoc modification of the images. It provides the ability to enhance the mucosal surface to better highlight mucosal changes.
These new imaging techniques have a theoretical advantage, which is extendedly used for sales purposes but so far has not been proven in the surveillance for precancerous or early cancer of the large bowel in patients with longstanding colitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Definition White Light | No intervention | –Surveillance colonoscopy using High Definition White Light alone |
| High Definition Virtualchromoendoscopy | Active comparator | Other: ChromoendoscopyHigh Definition Virtualchromoendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ulcerative Colitis or Crohn's colitis with a disease duration of >8 years for pancolitis or >15 years duration for left-sided colitis
- Aged 18 years and above
- Patients able to give informed consent
Key exclusion criteria (5 listed)
- Persistent coagulopathy or platelet count <50x1012 which may preclude mucosal biopsy
- Known colonic IN or CRC
- Fulminant colitis
- Patients who have been previously randomised and withdrawn on 2 occasions due to poor bowel preparation
- Patients who are pregnant
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 |
|---|---|---|
| ChromoendoscopyHigh definition virtual chromoendoscopy | Other | High Definition Virtualchromoendoscopy |
Primary outcome
To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy
Time frame: 14 months
2 secondary outcomes
To assess the neoplasia detection rate in targeted biopsies versus non-targeted (segmental) biopsies within each arm of the study
Time frame: 14 months
To compare the duration of time taken using each technique
Time frame: 14 months
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 26 Aug 2020.
- Derived from this study: PubMed 33214162Kandiah K, Subramaniam S, Thayalasekaran S, Chedgy FJ, Longcroft-Wheaton G, Fogg C, Brown JF, Smith SC, Iacucci M, Bhandari P. Multicentre randomised controlled trial on virtual chromoendoscopy in the detection of neoplasia during colitis surveillance high-definition colonoscopy (the VIRTUOSO trial). Gut. 2021 Sep;70(9):1684-1690. doi: 10.1136/gutjnl-2020-320980. Epub 2020 Nov 19.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromoendoscopy in people with Ulcerative Colitis and Crohn's Colitis, run by Portsmouth Hospitals 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 5 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 26 Aug 2020. 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?
To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy (time frame: 14 months). 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 NCT02822352, 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 26 Aug 2020.