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临床试验/NCT07079007
NCT07079007尚未招募不适用

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

Austin Health1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Austin Health
入组人数
55
试验地点
1
主要终点
Improvement of luminal distension of the terminal ileum

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Presence of an ostomy
  • Adequate distension at baseline scan
  • Patients with ileo-rectal anastomosis or IPAA

结局指标

主要结局

Improvement of luminal distension of the terminal ileum

时间窗: 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.

次要结局

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

研究者

发起方
Austin Health
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sheng Wei Lo

Principal Investigator: Julien Schulberg, MBBS, PhD , Austin Health, Melbourne

Austin Health

研究点 (1)

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