Use of Water Ingestion in Small Intestine Ultrasound

NCT ID: NCT07079007

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-02-28

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.

Conditions

Crohn Disease (CD); Intestine Ultrasonography

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

IUS oral contrast

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

Water

Intervention Type: OTHER

Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.

Interventions

Water

Patients that meet the inclusion and exclusion criteria would be asked to ingest 1000ml water as part of standard of care.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Austin Health

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheng Wei Lo

Principal Investigator: Julien Schulberg, MBBS, PhD , Austin Health, Melbourne

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Austin Health

Heidelberg, Victoria, Australia

Countries

Australia

Central Contacts

Sheng Wei Lo, MBBS

Role: CONTACT

shengwei.lo@austin.org.au

+61 3 94965000

Facility Contacts

Sheng Wei Lo

Role: primary

shengwei.lo@austin.org.au

+61 3 94965000

Other Identifiers

HREC/25015/Austin-2025

Identifier Type: -

Identifier Source: org_study_id