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
ID
Bron
Verkorte titel
Aandoening
Ulcerative colitis, inflammatory bowel diseases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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
Onderzoeksopzet
Baseline, week 1, week 2, week 6 and week 8-26
Onderzoeksproduct en/of interventie
Intestinal ultrasound
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Ulcerative colitis, histologically and endoscopically confirmed
• Endoscopically moderate to severe disease with a eMayo score ≥2
• Start of medical treatment
• >18 years of age
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
Register | ID |
---|---|
NTR-new | NL7903 |
Ander register | METC AMC : METC2019_007 |