NCT02543021

Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

Completed NA Last updated 31 August 2018

What this trial tests

NA trial testing Virtual chromoendoscopy in Inflammatory Bowel Disease in 60 participants. Completed in 1 February 2018.

Timeline

1 November 2015

Primary endpoint
1 November 2017

1 February 2018

Quick facts

Lead sponsor	King's College Hospital NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	diagnostic
Enrollment	60
Start date	1 November 2015
Primary completion	1 November 2017
Estimated completion	1 February 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Virtual chromoendoscopy
• Conventional chromoendoscopy

Conditions studied

• Inflammatory Bowel Disease — all drugs for Inflammatory Bowel Disease →

Sponsor

King's College Hospital NHS Trust

Who can join

Adults 18 to 75, any sex, with Inflammatory Bowel Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Faecal calprotectin is a surrogate marker of biliary inflammation in primary sclerosing cholangitis associated inflammatory bowel disease.
   Pavlidis P, Joshi D, El Sherif Y, Warner B, et al · · 2022 · cited 3× · PMID 36250171 · DOI 10.1136/flgastro-2021-102053