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NCT Number: NCT07079007

Use of Water Ingestion in Small Intestine Ultrasound

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.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestine Ultrasonography

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 and study plan

Water

Other

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

Primary outcomes

  1. Improvement of luminal distension of the terminal ileum

    Time frame: 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 outcomes

  1. 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

    Time frame: 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 outcomes

  1. Grade of peristalsis

    Time frame: 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)

  2. Identification of suspected stricture

    Time frame: 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)

  3. Measurement of bowel wall thickness

    Time frame: At the post-water ingestion scan 20-30 minutes after ingestion

    Bowel wall thickness of the terminal ileum and any diseased segment (in millimeters)

  4. Measurement of hyperaemia of the bowel wall of any diseased terminal ileal segment

    Time frame: 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)

  5. Pre-stenotic dilatation

    Time frame: 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

  6. Diet effeect on the study

    Time frame: 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

  7. Global assessment as assessed by blinded assessors

    Time frame: 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)

  8. Distension assessment

    Time frame: At the post-water ingestion scan 20-30 minutes after ingestion

    Binary assessment of distension - either poor or adequate

  9. Grade of peristalsis

    Time frame: At the post-water ingestion scan 20-30 minutes after ingestion

    Grade of peristalsis hyperkinetic / normal / decreased / absent

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Wei Lo, MBBS

CONTACT

[email protected]

+61 3 94965000

Sponsors and collaborators

Lead sponsor

Austin Health

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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