- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822352
RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis (VIRTUOSO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hampshire
-
Portsmouth, Hampshire, United Kingdom, PO6 3LY
- Portsmouth Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: High Definition White Light
Surveillance colonoscopy using High Definition White Light alone
|
|
Active Comparator: High Definition Virtualchromoendoscopy
|
High definition virtual chromoendoscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy
Time Frame: 14 months
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the neoplasia detection rate in targeted biopsies versus non-targeted (segmental) biopsies within each arm of the study
Time Frame: 14 months
|
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
|
14 months
|
To compare the duration of time taken using each technique
Time Frame: 14 months
|
This is measured by assessing the total withdrawal time taken in each arm of the study
|
14 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHT/2016/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ulcerative Colitis
-
Ferring PharmaceuticalsCompletedActive Ulcerative Colitis | Remission of Ulcerative ColitisCanada
-
Palatin Technologies, IncRecruitingUlcerative Colitis | Ulcerative Colitis Flare | Ulcerative Colitis Acute | UlcerativeUnited States
-
Theravance BiopharmaCompletedUlcerative Colitis, Active Severe | Ulcerative Colitis, Active ModerateUnited States, Georgia, Moldova, Republic of, Romania
-
Assistance Publique - Hôpitaux de ParisMRSU 938 - Research Center of Saint AntoineNot yet recruitingPediatric Ulcerative Colitis in RemissionFrance
-
Protagonist Therapeutics, Inc.CompletedUlcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic SevereUnited States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Korea, Republic of, Poland, Russian Federation, Serbia, Ukraine
-
Theravance BiopharmaCompletedActive Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsUnited States
-
Rise Therapeutics LLCUniversity of Colorado, Denver; Mayo ClinicRecruitingUlcerative Colitis | Ulcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic | Ulcerative Colitis Chronic MildUnited States
-
Groupe d'Etude Therapeutique des Affections Inflammatoires...CompletedIntensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET (In-TARGET)ULCERATIVE COLITISFrance, Belgium
-
Xijing Hospital of Digestive DiseasesNot yet recruitingUlcerative Colitis Chronic Moderate | Ulcerative Colitis Chronic Severe | Rectal UlcerChina
-
Altheus Therapeutics, Inc.UnknownUlcerative Colitis | Left-sided Ulcerative Colitis | Distal Ulcerative ColitisUnited States
Clinical Trials on Chromoendoscopy
-
Indiana University School of MedicineCompletedCrohn's Disease | Ulcerative ColitisUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedUlcerative Colitis | ChromoendoscopyNetherlands
-
King's College Hospital NHS TrustCompletedInflammatory Bowel DiseaseUnited Kingdom
-
VA Northern California Health Care SystemCompleted
-
Mayo ClinicCompletedColonic PolypsUnited States
-
Universitaire Ziekenhuizen KU LeuvenMcGill University; Maastricht University Medical Center; Copenhagen University... and other collaboratorsUnknownUlcerative ColitisBelgium, Canada, Denmark, Netherlands
-
The Leeds Teaching Hospitals NHS TrustCompletedUlcerative ColitisUnited Kingdom
-
Shandong UniversityTongji Hospital; Wuhan Union Hospital, China; Zhejiang UniversityUnknownDiagnostic Yield of Gastric NeoplasiaChina
-
KU LeuvenRecruitingDysplasia in Longstanding Achalasia | Relation Between Food Stasis and DysplasiaBelgium
-
Centre Hospitalier Universitaire de NiceCompleted