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Chromoendoscopy in Inflammatory Bowel Disease

NCT03250780 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-06-18

No results posted yet for this study

Summary

Patients with longstanding ulcerative colitis (inflammatory bowel disease, IBD) have increased risk of developing colorectal cancer (CRC) when compared with that of the general population. Therefore patients with longstanding colitis undergo regular screening colonoscopy at varied time intervals depending on their individual risk. This is thought to detect early mucosal (interior bowel lining) abnormalities, known as dysplasia, which can progress to CRC. Until recently, IBD surveillance has relied upon colonoscopy with multiple (at least 33) random biopsies of the bowel lining to detect dysplasia, but now international guidelines recommended a technique called chromoendoscopy.

Chromoendoscopy involves applying a dye, called indigo-carmine, to the bowel lining whilst performing colonoscopy which highlights more subtle abnormalities, therefore increasing dysplasia detection rate.

There is no standard international concentration of the dye spray used during chromoendoscopy. Studies have used different concentrations of indigo-carmine dye ranging from 0.1 to 0.4%. We have recently shown that 0.2% dye improves detection rates compared to high definition white light. The recent international SCENIC guidelines suggest using 0.03% indigo-carmine via a foot pump. However there are no trials comparing the two methods and no previous trials have used the 0.03%. We therefore aim to perform a randomised control trial, comparing 0.03% indigo-carmine dye versus 0.2% in detecting dysplasia in patients undergoing surveillance colonoscopy in IBD. Any lesions seen will assessed using standard endoscopic appearance but also using optical biopsy forceps to further characterise the lesion, then manage the lesion as standard guidelines. We will also take two additional rectal biopsies, which will be snap frozen in liquid nitrogen and then studied using Raman Spectroscopy, Infra Red spectroscopy and electrochemical impedance to develop optical markers to identify patients at higher risk of dysplasia.

Conditions

  • Colonoscopy

Interventions

PROCEDURE

indigo-carmine 0.2% using a spray catheter

PROCEDURE

0.03% using a foot pump

Sponsors & Collaborators

  • The Leeds Teaching Hospitals NHS Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-01-31
Completion
2021-01-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03250780 on ClinicalTrials.gov