To determine the accuracy of US for detecting disease activity in paediatric patients with IBD and to develop an easy-to-use and accurate US-activity index that can accelerate and improve clinical management by reducing the need for gastrointestinal…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic test accuracy of ultrasound as compared to golden standard imaging
(ileocolonoscopy or MRE).
Secondary outcome
Interobserver variability of US.
Background summary
Children with Inflammatory Bowel Disease (IBD) are exposed to a high number of
invasive diagnostic procedures (most frequently gastrointestinal endoscopies
and Magnetic Resonance Enterography (MRE)) during their lives. Most children
experience important anxiety during these procedures. In addition,
gastrointestinal endoscopies are more invasive in children compared to adults
due to the need for nasogastric tubes for bowel cleansing and general
anesthesia. To reduce this burden, moving towards a future with more accurate
non-invasive diagnostics is needed. Ultrasound (US) is a non-invasive, fast and
inexpensive way of imaging the bowel. However, little is known about its
accuracy in the paediatric population.
Study objective
To determine the accuracy of US for detecting disease activity in paediatric
patients with IBD and to develop an easy-to-use and accurate US-activity index
that can accelerate and improve clinical management by reducing the need for
gastrointestinal endoscopies and MRE.
Secondary objective: to assess the inter- and intra-observer variability of US.
Study design
A prospective observational study in paediatric patients with (suspicion of)
IBD. US will be performed concomitant with standard care ileocolonoscopy and
MRE. Accuracy of different US features (e.g. wall thickness, vascularisation,
lymph nodes, wall layer stratification) will be assessed per segment using
ileocolonoscopy as reference standard for large bowel and MRE for small bowel.
Subsequently an US-activity index based on the individual US parameters will be
composed using regression analysis. In addition inter- and intraobserver
variability of individual US features of the bowel and of the newly developed
US activity index will be determined.
Study burden and risks
Ultrasound is a safe, fast and non-invasive way of imaging, hence the extent of
the burden of participating is limited. There will be no direct benefits of
participating. However after completion of this study, patients might benefit
from the possibility to be monitored more accurately in a non-invasive manner.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
- Age 6-18
- Diagnosed with IBD or suspicion of IBD
- Undergoing MRE and/or endoscopy for routine care
Exclusion criteria
- Ongoing gastroenteritis
- Pregnancy
- Previous intestinal surgery
- Histologically proven CMV infection
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 | NL67729.018.18 |