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Use of Water Ingestion in Small Intestine Ultrasound

A

Austin Health

Status

Not yet enrolling

Conditions

Intestine Ultrasonography
Crohn Disease (CD)

Treatments

Other: Water

Study type

Observational

Funder types

Other

Identifiers

NCT07079007
HREC/25015/Austin-2025

Details and patient eligibility

About

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.

Enrollment

55 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

IUS oral contrast
Description:
All patients already referred and scheduled to undertake an IUS in the single-centre IUS clinic would undergo a baseline procedure. Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care. 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
Treatment:
Other: Water

Trial contacts and locations

1

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Central trial contact

Sheng Wei Lo, MBBS

Data sourced from clinicaltrials.gov

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