Chromoendoscopy in Inflammatory Bowel Disease

NCT ID: NCT03250780

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2021-01-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with extensive colitis

Patients with extensive colitis, for at least 8-10 years, already on the surveillance programme or newly referred whilst attending their outpatients IBD clinic at Leeds Teaching Hospitals NHS Trust will be screened by one of the research doctors who will be performing the surveillance colonoscopy.

Group Type: EXPERIMENTAL

indigo-carmine 0.2% using a spray catheter

Intervention Type: PROCEDURE

0.03% using a foot pump

Intervention Type: PROCEDURE

Interventions

indigo-carmine 0.2% using a spray catheter

Intervention Type: PROCEDURE

0.03% using a foot pump

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 1) Patients with longstanding (more than 8 years of disease), extensive (extending proximal to splenic flexure) colitis attending for surveillance colonoscopy. 2) Patients aged over 18 years of age 3) Patients with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease colitis.

Exclusion Criteria

• 1) Pregnant 2) Unwilling or unable to give informed consent 3) Severe active colitis 4) Poor bowel preparation 5) Unable to reach the caecum

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Venkataraman Subramanian, MBBS, MRCP, MD

Role: CONTACT

venkat.subramanian@nhs.net

Richard Lord, MBChB, MRCP

Role: CONTACT

richard.lord2@nhs.net

Other Identifiers

GA16/89362

Identifier Type: -

Identifier Source: org_study_id