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 designSingle-center observational study
Primary study designObservational
Secondary study design
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleHistological remission in ulcerative colitis: comparing histological activity indexes - an observational study
Study objectivesTo 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) studiedUlcerative colitis
InterventionBiopsies 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 typeOther
Primary outcome measureIntra- and inter-observer variability all histological indices
Secondary outcome measuresThe relationship with endoscopic mucosal healing, and the relationship between the initial judgment of the primary pathologist in all scoring systems
Overall study start date01/10/2015
Completion date01/04/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants50
Key inclusion criteria1. 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 criteria1. Mayo endoscopic score > 1
2. Diagnosed with either Crohn’s disease or indeterminate colitis
Date of first enrolment01/10/2015
Date of final enrolment01/12/2015

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 logo "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 shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe trialists intend to publish the results only and not the protocol at this stage.
IPD sharing plan