Chromoendoscopy in Inflammatory Bowel Disease
Primary Purpose
Colonoscopy
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
indigo-carmine 0.2% using a spray catheter
0.03% using a foot pump
Sponsored by
About this trial
This is an interventional diagnostic trial for Colonoscopy
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
Sites / Locations
- Leeds Teaching Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with extensive colitis
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of patients with at least low grade dysplasia detected by targeted biopsy using 0.2% indigo-carmine compared with 0.03% indigo-carmine.
Secondary Outcome Measures
Full Information
NCT ID
NCT03250780
First Posted
August 11, 2017
Last Updated
June 17, 2019
Sponsor
The Leeds Teaching Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03250780
Brief Title
Chromoendoscopy in Inflammatory Bowel Disease
Official Title
Chromoendoscopy With 0.03% Indigo-carmine Delivered Via a Foot Pump Compared With 0.2% Indigo-carmine Delivered Via Spray Catheter for Detecting Dysplasia in Patients Undergoing Surveillance in Inflammatory Bowel Disease. A Randomized Control Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Leeds Teaching Hospitals NHS Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with extensive colitis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
indigo-carmine 0.2% using a spray catheter
Intervention Type
Procedure
Intervention Name(s)
0.03% using a foot pump
Primary Outcome Measure Information:
Title
Number of patients with at least low grade dysplasia detected by targeted biopsy using 0.2% indigo-carmine compared with 0.03% indigo-carmine.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Venkataraman Subramanian, MBBS, MRCP, MD
Email
venkat.subramanian@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Richard Lord, MBChB, MRCP
Email
richard.lord2@nhs.net
Facility Information:
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS1 3HE,
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Chromoendoscopy in Inflammatory Bowel Disease
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