Histological remission in ulcerative colitis: comparing histological activity indexes

ISRCTN	ISRCTN61139227
DOI	https://doi.org/10.1186/ISRCTN61139227
Secondary identifying numbers	2015-1993

Submission date: 22/09/2015
Registration date: 24/09/2015
Last edited: 10/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Ulcerative colitis (UC) is a long-term relapsing disease affecting the large intestine (colon). Its main symptoms are diarrhoea, abdominal pain and tiredness. Previously the target of treatment for these patients was clinical remission (i.e., reduced symptoms). Recently the aim of treatment changed and doctors now try to achieve normal intestinal tissue (mucosa) at endoscopy, called mucosal healing. A new treatment target has been developed called microscopic mucosal healing, where tissue samples taken from the colon (colonic biopsies) are assessed under a microscope using a scoring system and found to be normal, but it is not yet clear which scoring system to use for this. The aim of the study is to compare three commonly used scoring systems for microscopic mucosal healing in ulcerative colitis.

Who can participate?
Patients with ulcerative colitis who have already undergone a colonoscopy.

What does the study involve?
Colonic biopsies taken from the participants at a previous colonoscopy are studied. These biopsies are re-assessed by three specialist doctors using three different scoring systems. The participants do not need to have a colonoscopy again.

What are the possible benefits and risks of participating?
A single scoring system will result in a better disease outcome for ulcerative colitis patients in the future. There are no possible risks because the biopsies were taken at a previous colonoscopy.

Where is the study run from?
Radboud University Medical Center (Netherlands).

When is the study starting and how long is it expected to run for?
October 2015 to April 2016.

Who is funding the study?
Investigator initiated and funded (Netherlands).

Who is the main contact?
Tessa Römkens

Contact information

Mrs Tessa Römkens
Scientific

Radboud University Medical Center
Department of Gastroenterology & Hepatology
PO Box 9101
Nijmegen
6500 HB
Netherlands

Study information

Study design	Single-center observational study
Primary study design	Observational
Secondary study design
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Histological remission in ulcerative colitis: comparing histological activity indexes - an observational study
Study objectives	To compare and validate three commonly used histological scoring systems in order to define histological mucosal healing (MH).
Ethics approval(s)	Ethics Committee of Radboud University Medical Center, 27/08/2015, ref: 2015-1993
Health condition(s) or problem(s) studied	Ulcerative colitis
Intervention	Biopsies were taken during colonoscopy from patients with quiescent UC with endoscopical MH (Mayo score ≤ 1). All biopsies were reassessed by three blinded pathologists using the Gupta, Riley and Geboes histology scoring systems, and a global visual evaluation (GVE).
Intervention type	Other
Primary outcome measure	Intra- and inter-observer variability all histological indices
Secondary outcome measures	The relationship with endoscopic mucosal healing, and the relationship between the initial judgment of the primary pathologist in all scoring systems
Overall study start date	01/10/2015
Completion date	01/04/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	50
Key inclusion criteria	1. A colonoscopic examination between January 2014 and July 2015 2. A well-established diagnosis of UC according to clinical and histological criteria 3. Endoscopic mucosal healing throughout the entire colon according to Mayo (≤1) 4. Randomly taken colonic biopsy specimens in both left and right colon with a clear description of the microscopic features by the pathologist
Key exclusion criteria	1. Mayo endoscopic score > 1 2. Diagnosed with either Crohn’s disease or indeterminate colitis
Date of first enrolment	01/10/2015
Date of final enrolment	01/12/2015

Locations

Countries of recruitment

Netherlands

Study participating centre

Radboud University Medical Center

Nijmegen
6500 HB
Netherlands

Sponsor information

Radboud University Medical Center (Netherlands)
Hospital/treatment centre

PO Box 9101
Nijmegen
6500 HB
Netherlands

"ROR"	https://ror.org/05wg1m734

Funders

Funder type

Other

Investigator initiated and funded (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The trialists intend to publish the results only and not the protocol at this stage.
IPD sharing plan