Use of Water Ingestion in Small Intestine Ultrasound

Use of Water Ingestion to Improve Visualisation in Small Intestine Ultrasound (WIVIUS): Single Centre Blinded Crossover Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD); Intestine Ultrasonography
• Intervention / Treatment: Other: Water

• Study Type: Observational
• Enrollment (Estimated): 55

Contacts and Locations

• Study Contact: Name: Sheng Wei Lo, MBBS; Phone Number: +61 3 94965000; Email: shengwei.lo@austin.org.au

Study Locations

• Australia
  • Victoria
    • Heidelberg, Victoria, Australia, 3084
      • Austin Health
      • Contact: Sheng Wei Lo; Phone Number: +61 3 94965000; Email: shengwei.lo@austin.org.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients already referred and scheduled to undertake an IUS in the single-centre Austin Health 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of luminal distension of the terminal ileum	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.	At the post-water ingestion scan 20-30 minutes after ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	At the time of post-water ingestion scan 20-30 minutes after ingestion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grade of peristalsis	At the time of scan, determine grade of peristalsis (hyperkinetic, normal, decreased, absent)	At the time of post-water ingestion scan 20-30 mins after ingestion
Identification of suspected stricture	Identification of suspected stricture with documentation of changes post WICUS (measured luminal distension in millimeters)	At the post-water ingestion scan 20-30 minutes after ingestion
Measurement of bowel wall thickness	Bowel wall thickness of the terminal ileum and any diseased segment (in millimeters)	At the post-water ingestion scan 20-30 minutes after ingestion
Measurement of hyperaemia of the bowel wall of any diseased terminal ileal segment	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)	At the post-water ingestion scan 20-30 minutes after ingestion
Pre-stenotic dilatation	Measurement of prestenotic luminal distension (in millimeters) proximal to any diseased terminal ileum segment	At the post-water ingestion scan 20-30 minutes after ingestion
Diet effeect on the study	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	At the post-water ingestion scan 20-30 minutes after ingestion
Global assessment as assessed by blinded assessors	Likert scale (5 point) global assessment 1-5 (1=Poor/inadequate views, 5=excellent view)	At the post-water ingestion scan 20-30 minutes after ingestion
Distension assessment	Binary assessment of distension - either poor or adequate	At the post-water ingestion scan 20-30 minutes after ingestion
Grade of peristalsis	Grade of peristalsis hyperkinetic / normal / decreased / absent	At the post-water ingestion scan 20-30 minutes after ingestion

Collaborators and Investigators

• Sponsor: Austin Health

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 30, 2025
• First Submitted That Met QC Criteria: July 18, 2025
• First Posted (Actual): July 22, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: small bowel contrast ultrasound
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: HREC/25015/Austin-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No