Use of Water Ingestion in Small Intestine Ultrasound

N/ANot Yet RecruitingNCT07079007

Austin Health55 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Crohn Disease (CD)Intestine Ultrasonography

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

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