No registrations found.
ID
Source
Brief title
Health condition
Ulcerative colitis, inflammatory bowel diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study will be change in bowel wall width in millimetres within 0 to 26 weeks against the reference standard of endoscopy where response on endoscopy is defined as a decrease of at least 1 point in eMayo-score at follow-up endoscopy after 8 to 26 weeks.
Secondary outcome
• Change of other ultrasound parameters within 0 to 26 weeks against both eMayo and UCEIS at follow-up endoscopy between week 8 and 26
• Change of all ultrasound parameters within 0 to 26 weeks against clinical response according to clinical disease activity indices (Mayo, SCCAI)
• Change of all ultrasound parameters within 0 to 26 weeks against biochemical parameters (blood and faecal parameters)
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS)
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission on follow-up endoscopy between week 8 and 26 (eMayo, UCEIS)
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on clinical disease activity indices (Mayo, Lichtiger score)
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting remission according to clinical disease activity indices (Mayo, SCCAI, Lichtiger score)
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting response to treatment according to response based on biochemical parameters (faecal calprotectin, CRP)
• Ultrasound parameters at baseline predicting deterioration in acute severe ulcerative colitis according to Oxford criteria
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting colectomy within 0 to 26 weeks.
• Ultrasound parameters at baseline, week 1, 2 and 6 predicting failing steroid treatment
Background summary
Ulcerative colitis (UC) is an inflammatory bowel disease characterised by a pattern of relapse and remission. A moderate to severe relapse is frequently seen during disease course and needs medical treatment. Moreover, acute severe ulcerative colitis (ASUC) is a life-threatening complication, which occurs in approximately 20% to 30% of UC patients during their disease course and results in high colectomy rates since many patients fail to medical rescue treatment. In order to improve outcome, it is of major importance to assess effect of treatment in an early stage to adapt treatment accordingly. Several clinical and biochemical data predict failure to response but also show lack of reliability. Although endoscopy is the gold standard in evaluating UC disease activity, it is challenging to perform this exam repeatedly in patients. Indeed endoscopy is invasive, expensive and comes with adverse events and is therefore not optimal in the close monitoring of moderate to severe UC patients. In addition to clinical, biochemical and endoscopic parameters, cross sectional imaging may show response to treatment already in the first days to weeks. Trans-abdominal ultrasound of the colon correlates well with other radiological methods (e.g MRI and CT) and colonoscopy. Furthermore, ultrasound is a method which is non-invasive, cheap and easy to perform which makes it an excellent choice to assess disease activity frequently during the first weeks of medical treatment.
Study objective
The response on medical treatment for moderate to severe ulcerative colitis is visible on intestinal ultrasound within the first 6 weeks according to endoscopic response at 8-26 weeks
Study design
Baseline, week 1, week 2, week 6 and week 8-26
Intervention
Intestinal ultrasound
Inclusion criteria
• Ulcerative colitis, histologically and endoscopically confirmed
• Endoscopically moderate to severe disease with a eMayo score ≥2
• Start of medical treatment
• >18 years of age
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Proctitis only
• Colonic stricture at baseline endoscopy
• Imminent need of surgery
• Sigmoidoscopy/colonoscopy older than eight weeks
• Ongoing gastroenteritis
• Cytomegalovirus (CMV) associated colitis
• Obesity (BMI >35 kg/m²)
• A normal bowel wall < 2mm at baseline ultrasonography
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7903 |
| Other | METC AMC : METC2019_007 |