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

Primary Purpose

Ulcerative Colitis, Crohn's Colitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Chromoendoscopy
Sponsored by
Portsmouth Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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  • Patients who have been previously randomised and withdrawn on 2 occasions due to poor bowel preparation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

Sites / Locations

  • Portsmouth Hospitals NHS trust

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

High Definition White Light

High Definition Virtualchromoendoscopy

Arm Description

Surveillance colonoscopy using High Definition White Light alone

High Definition Virtualchromoendoscopy

Outcomes

Primary Outcome Measures

To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy

Secondary Outcome Measures

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
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

Full Information

First Posted
June 29, 2016
Last Updated
August 24, 2020
Sponsor
Portsmouth Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02822352
Brief Title
RCT: HDWL vs Virtual Chromoendoscopy in the Detection of Intraepithelial Neoplasia in Longstanding Colitis
Acronym
VIRTUOSO
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 Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
March 8, 2018 (Actual)
Study Completion Date
August 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Portsmouth Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Crohn's Colitis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Definition White Light
Arm Type
No Intervention
Arm Description
Surveillance colonoscopy using High Definition White Light alone
Arm Title
High Definition Virtualchromoendoscopy
Arm Type
Active Comparator
Arm Description
High Definition Virtualchromoendoscopy
Intervention Type
Other
Intervention Name(s)
Chromoendoscopy
Intervention Description
High definition virtual chromoendoscopy
Primary Outcome Measure Information:
Title
To compare the rates of neoplasia detection using virtual chromoendoscopy compared to high definition white light (HDWL) endoscopy
Time Frame
14 months
Secondary Outcome Measure Information:
Title
To assess the neoplasia detection rate in targeted biopsies versus non-targeted (segmental) biopsies within each arm of the study
Description
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
Time Frame
14 months
Title
To compare the duration of time taken using each technique
Description
This is measured by assessing the total withdrawal time taken in each arm of the study
Time Frame
14 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Portsmouth Hospitals NHS trust
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33214162
Citation
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.
Results Reference
derived

Learn more about this trial

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

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