PROSPERS Study v3.1
Research type
Research Study
Full title
New endoscopic scoring system using virtual electronic chromoendoscopy to characterise mucosal and vascular details and predict the risk of clinical recurrence in post-operative Crohn’s Disease: a prospective multicentre international study
IRAS ID
270395
Contact name
Marietta Iacucci
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
4 years, 6 months, 1 days
Research summary
Crohn’s Disease is a chronic, relapsing disease which may lead to long-term disability and impaired quality of life. Clinical course is unpredictable but many patients require surgery at some time. Unfortunately, surgery is not curative and there is an increased risk of further surgery. Therefore, prevention of post-operative recurrence is a major challenge. By more accurately assessing the risk of recurrence, therapy may be targeted and thus reduce the risk of further surgery.\nAdvances in endoscopic techniques may allow more accurate assessment of risk. The PROSPERS study aims to develop and validate a new endoscopic scoring system to help predict the risk of recurrence in post-operative Crohn’s Disease.\nIt is intended to recruit patients from two sites in the UK. Additional sites will recruit overseas. Patients will have received, or be scheduled for, surgery for Crohn’s Disease. Study procedures will be carried out as part of routine care, and it is not intended that additional hospital visits will be required. \nDuring post-operative colonoscopy (approximately 3-6 months following surgery), patients will undergo high definition white light endoscopy (WLE), followed by Virtual Electronic Chromoendoscopy (VCE). Certain sites will also use probe Confocal Laser Endomicroscopy (pCLE), which gives microscopic images similar to those seen in the lab. If pCLE is performed, then patients will require an intravenous fluorescein injection. This has been used as a contrast agent for several years and has well documented safety profile. \nDuring the procedure biopsies (tissue samples) will be taken. These will be digitalised and examined in order to develop the score. Patients will consent to digitalisation and storage of digitalised images.\nAt one site only (University Hospitals Birmingham) additional tissue samples will be taken for analysis to provide additional information about Crohn’s Disease such as identification of biomarkers which could help in targeting therapy. \n
REC name
North of Scotland Research Ethics Committee 1
REC reference
20/NS/0026
Date of REC Opinion
17 Feb 2020
REC opinion
Favourable Opinion