Ignite Creation Date:
2024-05-06 @ 7:29 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02543021
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2015-09-04
Brief Title:
Virtual Chromoendoscopy for Colitis Surveillance A Feasibility Study
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
A Study to Assess the Feasibility and Patient Acceptability of a Randomised Crossover Design to Compare Virtual vs Conventional Chromoendoscopy for the Detection of Dysplasia in Colitis
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with colitis require regular surveillance colonoscopy as their risk of developing colon cancer is at least 25 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 participants 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
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 participants 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
Detailed Description:
In the recruitment period 60 patients will be approached when they are invited to attend for scheduled surveillance colonoscopy Eligible patients 18-75 yrs who agree to participate will be randomised to undergo CE or VCE as the first procedure Data will be captured by an Observer using a bespoke Access-based program
The site and number of any biopsy samples taken will be recorded alongside the Endoscopists prediction based on visual appearance of whether they think the area biopsied is actually dysplasia
After an agreed interval no more than 8 weeks usually 3-6 participants will undergo a second colonoscopy with the second technique performed by an Endoscopist blinded to the results of the first test and data captured as before For each procedure a questionnaire assessing immediate patient experience will be administered in the Endoscopy department after the participant has recovered from the procedure Participants will also be given a second questionnaire assessing their overall experience to take home and complete 48 hours after the procedure which will be returned by post
The site and number of any biopsy samples taken will be recorded alongside the Endoscopists prediction based on visual appearance of whether they think the area biopsied is actually dysplasia
After an agreed interval no more than 8 weeks usually 3-6 participants will undergo a second colonoscopy with the second technique performed by an Endoscopist blinded to the results of the first test and data captured as before For each procedure a questionnaire assessing immediate patient experience will be administered in the Endoscopy department after the participant has recovered from the procedure Participants will also be given a second questionnaire assessing their overall experience to take home and complete 48 hours after the procedure which will be returned by post
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None