Use of Water Ingestion in Small Intestine Ultrasound

ConditionsCrohn Disease (CD)Intestine Ultrasonography

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorAustin Health

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Presence of an ostomy

Adequate distension at baseline scan

Patients with ileo-rectal anastomosis or IPAA

Trial 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.

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

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

Treatment groups

55 Participants

are divided into 1 treatment group

Group A: IUS oral contrast1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

At the post-water ingestion scan 20-30 minutes after ingestion

Secondary outcomes

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

Time frame

At the time of post-water ingestion scan 20-30 minutes after ingestion

Other outcomes

Grade of peristalsis

At the time of scan, determine grade of peristalsis (hyperkinetic, normal, decreased, absent)

Time frame

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)

Time frame

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)

Time frame

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)

Time frame

At the post-water ingestion scan 20-30 minutes after ingestion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Austin Health

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: