Histological remission in ulcerative colitis: comparing histological activity indexes
| ISRCTN | ISRCTN61139227 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61139227 |
| Protocol serial number | 2015-1993 |
| Sponsor | Radboud University Medical Center (Netherlands) |
| Funder | Investigator initiated and funded (Netherlands) |
- 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
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
Scientific
Radboud University Medical Center
Department of Gastroenterology & Hepatology
PO Box 9101
Nijmegen
6500 HB
Netherlands
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-center observational study |
| Secondary study design | |
| Study type | Participant 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(s) |
Intra- and inter-observer variability all histological indices |
| Key secondary outcome measure(s) |
The relationship with endoscopic mucosal healing, and the relationship between the initial judgment of the primary pathologist in all scoring systems |
| Completion date | 01/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
6500 HB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
