Virtual Chromoendoscopy for Colitis Surveillance: A Feasibility Study

NCT02543021 | Completed DMC

• 1 other identifier: 113398
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease

Keywords

Colitis; Dysplasia; Chromoendoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Patient experience assessed by validated questionnaire

  2 years

• Procedure time

  2 years

• Miss rate for dysplasia

  2 years

• Prediction of histology

  2 years

Study Arms (2)

Conventional chromoendoscopy

ACTIVE COMPARATOR

Patients will undergo colitis surveillance colonoscopy with indigo carmine chromoendoscopy (dye spray)

Procedure: Conventional chromoendoscopy

Virtual chromoendoscopy

EXPERIMENTAL

Patients will undergo colitis surveillance colonoscopy with FICE(TM) virtual chromoendoscopy

Device: Virtual chromoendoscopy

Interventions

Virtual chromoendoscopy DEVICE

Digital / virtual chromoendoscopy with FICE

Also known as: Fujinon Intelligent Color Enhancement (FICE)

Virtual chromoendoscopy

Conventional chromoendoscopy PROCEDURE

Conventional chromoendoscopy with indigo carmine dye spray

Also known as: Indigo carmine dye spray

Conventional chromoendoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to provide informed
• Written consent

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36250171 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases

Study Officials

• Bu'Hussain Hayee, FRCP

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: February 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)