Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Procedure: Conventional chromoendoscopy; Device: Virtual chromoendoscopy

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 Endoscopist's 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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Any patient eligible for colitis surveillance colonoscopy by British Society of Gastroenterology guidelines:

• Ulcerative pan-proctocolitis or Crohn's colitis of 8 or more years duration
• With or without co-diagnosis of primary sclerosing cholangitis

Exclusion Criteria:

• Inability to provide informed
• Written consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Conventional chromoendoscopy; Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray)	Procedure: Conventional chromoendoscopy; Conventional chromoendoscopy with indigo carmine dye spray; Other Names: Indigo carmine dye spray
EXPERIMENTAL: Virtual chromoendoscopy; Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy	Device: Virtual chromoendoscopy; Digital / virtual chromoendoscopy with FICE; Other Names: Fujinon Intelligent Color Enhancement (FICE)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient adherence to study design - success of recruitment (minimum recruitment of 75%) and retention of patients (minimum target of 75%)	The investigators are evaluating the success of recruitment to the study design with a target minimum recruitment of 75%; The investigators will also evaluate retention of patients within the crossover study design with a minimum target of 75%	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient experience assessed by validated questionnaire	Patient experience of the procedure in both arms will be compared (intra-individual) by validated questionnaire	2 years
Procedure time	The time taken for each procedure will be compared (average)	2 years
Miss rate for dysplasia	The miss rate of each technique will be compared	2 years
Prediction of histology	The ability of conventional vs virtual chromoendoscopy will be compared to predict eventual histology of targeted biopsies (from which a sensitivity and specificity will be calculated)	2 years

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Investigators: Principal Investigator: Bu'Hussain Hayee, FRCP, King's College Hospital NHS Trust

Publications and helpful links

General Publications

• Pavlidis P, Joshi D, El Sherif Y, Warner B, Gulati S, Alexander J, Cross G, Dew T, Arqoub HA, Devlin J, Heneghan M, Dubois P, Bjarnason I, Powell N, Hayee B. Faecal calprotectin is a surrogate marker of biliary inflammation in primary sclerosing cholangitis associated inflammatory bowel disease. Frontline Gastroenterol. 2022 Mar 18;13(6):497-502. doi: 10.1136/flgastro-2021-102053. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2015
• Primary Completion (ACTUAL): November 1, 2017
• Study Completion (ACTUAL): February 1, 2018

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 4, 2015
• First Posted (ESTIMATE): September 7, 2015

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Chromoendoscopy; Colitis; Dysplasia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Colitis
• Other Study ID Numbers: 113398

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Patient level data will not be shared. Cohort results will form publication/output