Use of Water Ingestion in Small Intestine Ultrasound

Not yet recruiting

• Conditions: Crohn Disease (CD); Intestine Ultrasonography

• Registration Number: NCT07079007
• Lead Sponsor: Austin Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study Start: 2025-07-01
• Study First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2025-11
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Heidelberg, Victoria, Australia