Crohn Disease (CD), Intestine Ultrasonography
Conditions
Keywords
small bowel contrast ultrasound
Brief summary
Small Intestine Contrast Ultrasonography (SICUS) is an ultrasound-based method that explores bowel loops, and is able to identify wall thickness, intestinal motility, bowel wall vascularity and complications such as stenosis or dilatation. Previous studies have utilised oral ingestion of an oral contrast solution (usually PEG dissolved in a volume of water ranging from 250 to 1000mL), in order to increase the sensitivity of ultrasound, especially in stricture detection. Parameters that have been improved include lumen distension to better delineate bowel wall layers, and improved peristalsis. Diffusion of this technique has been limited, in part due to PEG-based agents being costly, time consuming and are not tolerated well in some individuals. Utilisation of water as oral contrast may improve patient tolerability and therefore increase uptake of water ingested intestinal contrast ultrasound (WICUS) as a technique in routine clinical practice. The investigators aim to study the tolerability and the improvement of image quality utilising water as an oral contrast for intestinal ultrasonography.
Interventions
OTHERWater
Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.
Sponsors
Austin Health
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
All consecutive patients at baseline scan with: * Confirmed or suspected Crohn's disease with small bowel involvement * Increased bowel wall thickness (\>3mm) of the terminal ileum * Suboptimal luminal distension of the terminal ileum 3cm proximal to ICV and 1cm proximal to diseased segment (defined as \<8mm) * All patients with an ileo-colic anastomosis
Exclusion criteria
* Presence of an ostomy * Adequate distension at baseline scan * Patients with ileo-rectal anastomosis or IPAA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of luminal distension of the terminal ileum | At the post-water ingestion scan 20-30 minutes after ingestion | Improvement of luminal distension of the terminal ileum, defined as increase of 20% over baseline luminal diameter at the terminal ileum if no disease, taking the average as measured at 1cm intervals over 3cm of the TI in longitudinal view. If diseased segment is present, then measurements would be done at 1cm intervals over 3cm proximal to the diseased segments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Is image quality and visualisation of the terminal/distal ileum improved post water ingestion during intestinal ultrasound compared to baseline as assessed by blinded sonographers | At the time of post-water ingestion scan 20-30 minutes after ingestion | Recordings of the IUS would be recorded and de-identified Pre-contrast Cineloop x 1 of 10second duration encompassing the caecum, ileocaecal valce, terminal ileum extending to distal ileum Post-contrast Cineloop x 1 of 10second duration encompassing the caecum, ileocaecal valce, terminal ileum extending to distal ileum De-identified cineloops will then be randomised in a paired fashion (2 x cineloops baseline and 2 x cineloops post-contrast), and 3 external blinded sonographers will then be invited to review the cineloops - no limitation to number of times - and complete a questionnaire. Based on before and after CINE look in random order Global (overall image) assessment. Options: Better / Unchaged / Worse of CINEloop 1 compared to CINEloop 2 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identification of suspected stricture | At the post-water ingestion scan 20-30 minutes after ingestion | Identification of suspected stricture with documentation of changes post WICUS (measured luminal distension in millimeters) |
| Measurement of bowel wall thickness | At the post-water ingestion scan 20-30 minutes after ingestion | Bowel wall thickness of the terminal ileum and any diseased segment (in millimeters) |
| Measurement of hyperaemia of the bowel wall of any diseased terminal ileal segment | At the post-water ingestion scan 20-30 minutes after ingestion | Assessment of the bowel wall with colour doppler, and grading hyperaemia with the modified Limberg score (0 = no vascularity, 1 = localised vascularity, 2 = extensive vascularity, 3 = hyperemia extending into mesentery) |
| Pre-stenotic dilatation | At the post-water ingestion scan 20-30 minutes after ingestion | Measurement of prestenotic luminal distension (in millimeters) proximal to any diseased terminal ileum segment |
| Global assessment as assessed by blinded assessors | At the post-water ingestion scan 20-30 minutes after ingestion | Likert scale (5 point) global assessment 1-5 (1=Poor/inadequate views, 5=excellent view) |
| Distension assessment | At the post-water ingestion scan 20-30 minutes after ingestion | Binary assessment of distension - either poor or adequate |
| Diet effeect on the study | At the post-water ingestion scan 20-30 minutes after ingestion | To determine if fasted patients (\>2 hours no fluid and \>3 hours no solid food \[meal/snack/nothing\]) were more likely to be included in the study due to lesser luminal distention |
| Grade of peristalsis | At the time of post-water ingestion scan 20-30 mins after ingestion | At the time of scan, determine grade of peristalsis (hyperkinetic, normal, decreased, absent) |
Countries
Australia
Contacts
Primary ContactSheng Wei Lo, MBBS
Outcome results
None listed