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RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis (VIRTUOSO)

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: NCT02822352
Recruitment Status : Completed
First Posted : July 4, 2016
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
Portsmouth Hospitals NHS Trust

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Ulcerative Colitis Crohn's Colitis Other: Chromoendoscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : August 2016
Actual Primary Completion Date : March 8, 2018
Actual Study Completion Date : August 7, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: High Definition White Light
Surveillance colonoscopy using High Definition White Light alone
Active Comparator: High Definition Virtualchromoendoscopy
High Definition Virtualchromoendoscopy
Other: Chromoendoscopy
High definition virtual chromoendoscopy




Primary Outcome Measures :
  1. To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822352


Locations
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United Kingdom
Portsmouth Hospitals NHS trust
Portsmouth, Hampshire, United Kingdom, PO6 3LY
Sponsors and Collaborators
Portsmouth Hospitals NHS Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Portsmouth Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02822352    
Other Study ID Numbers: PHT/2016/02
First Posted: July 4, 2016    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases