The primary objective of this study is to identify ultrasonographic parameters that indicate response to treatment in moderate to severe UC. Accordingly, a secondary objective is to create an ultrasonographic scoring model which predicts response.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint of this study will be difference in change of bowel wall
width within 26 weeks between the responding and non-responding group.
Secondary outcome
Ultrasonographic endpoints at week 0, 1, 2, 6 and between week 8 and 26:
Lumen width (millimetres)
Bowel wall thickness measured from the hyperechoic lumen to the
hypoechoic muscularis propra (millimetres)
Loss of stratification of the colon wall (yes/no)
Layer thickness (mucosa, submucosa, muscularis propria in millimetres)
Colon wall perfusion following the Limberg score
Disease extent (areas affected)
Loss of haustrae (yes/no)
Mesenteric lymph nodes (yes/no)
Abscesses (yes/no)
Examination time (minutes)
Visibility (0-3 point scale)
Faecal calprotectin
Remission < 250 mg/g
Inflammatory parameters (C-reactive protein, haemoglobin, erythrocyte count,
leukocyte count, thrombocyte count, albumin)
Remission:
CRP * 5 mg/L
Clinical disease activity scores (Mayo score, Lichtiger score, SCCAI, Oxford
criteria)
Clinical response:
A decrease in Mayo score * 3
Lichtiger score <10 with a decrease of at least 3
Remission:
SCCAI * 2
Mayo score * 2 with all subscores *1
Lichtiger score * 3
Deterioration in acute severe ulcerative colitis:
Oxford criteria at day 3 to 5: *8 stools/day or >3 but <8
stools/day+CRP>45 mg/mL
Endoscopic disease activity
Response (UCEIS): decrease of 2 points in UCEIS at follow-up endoscopy at 8
to 26 weeks.
Remission (UCEIS): UCEIS * 1
Remission (Mayo): Mayo * 1
Other study parameters
Steroid refractory rate within 26 weeks
Infliximab trough levels at week 2 and 6
Colectomy rate within 26 weeks
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 primary objective of this study is to identify ultrasonographic parameters
that indicate response to treatment in moderate to severe UC. Accordingly, a
secondary objective is to create an ultrasonographic scoring model which
predicts response.
Study design
Prospective longitudinal study, mono-center
Patients with at least Mayo 2 endoscopic disease activity will be eligible for
inclusion. Then, at start of medical treatment, week 1, 2 and 6 an intestinal
ultrasound will be performed. Furthermore, at week 2 and 6 biochemical
parameters will be collected. Between week 8 and 26 patients will receive a(n)
(second) endoscopy as per standard of protocol with corresponding
ultrasonography and biochemical parameters.
Study burden and risks
In this group of patients it is extremely important to assess effect of
treatment in an early stage. In current standard care, patients receive
treatment and subsequently endoscopy is repeated within 8 to 26 weeks to show
whether treatment is effective. It would be meaningful to have another
complementary modality to assess disease activity that could be used more
frequently and in an early stage after onset of treatment. Ultrasonography is
such a promising, accurate, non-invasive and cheap modality and could therefore
be a potential marker reflecting disease activity and indicating effect of
treatment.
Adjacent to the standard care protocol patients will receive multiple
ultrasonographic examinations. The additional burden of this study is therefore
considered low whereas the potential benefit is considered high.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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
*Age<18years
*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
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 |
|---|---|
| CCMO | NL68692.018.19 |