Menu
Not yet recruiting NCT07079007

Use of Water Ingestion in Small Intestine Ultrasound

Observational Crohn Disease (CD) Intestine Ultrasonography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Water.
Who it may be relevant to
Registry conditions: Crohn Disease (CD), Intestine Ultrasonography. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Improvement of luminal distension of the terminal ileum [Time frame: At the post-water ingestion scan 20-30 minutes after ingestion]
Secondary outcome measures (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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Australia · 1 center
  • Austin Health — Heidelberg

Identifiers

NCT: NCT07079007 · HREC/25015/Austin-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗