跳至主要内容
临床试验/NCT06686589
NCT06686589尚未招募不适用

The Utility of Hand-held Ultrasound Devices to Detect Bowel Wall Inflammatory Activity in Crohn's Disease

Sheba Medical Center0 个研究点目标入组 150 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
主要终点
The capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.

研究概览

简要总结

One of the major obstacles in implementing intestinal ultrasound services for inflammatory bowel disease (IBD) patients relates to the costs of acquiring ultrasound (US) machines. The costs of high-end (and higher levels of quality) US machines are considerable, and although large medical centers in developed countries can obtain US machines, smaller centers in rural areas, community centers and centers in undeveloped countries may struggle with the cost of the machines. The lack of availability of point-of-care intestinal ultrasound impedes the medical treatment IBD patients receive. Recently, new models of hand-held small ultrasound machines were introduced to the market by large ultrasound companies. These machines are affordable and are used mainly for point-of-care ultrasound exams. We hypothesize that if the image quality acquired by these machines is proven to be good enough for the detection of bowel inflammation and complications in Crohn's disease (CD) patients, the use of intestinal ultrasound can potentially increase, allowing better care for CD patients.

Our idea is to compare the accuracy of various hand-held ultrasound devices to detect ultrasonographic signs of bowel inflammatory activity (especially increased bowel wall thickness) to that of high-end and premium US machines. The first part of the project will include examining the quality of 2 different hand-held US machines (GE VSCAN air and Philips Lumify) by 3 experienced ultra-sonographers. If the achieved level of accuracy for the detection of bowel wall inflammatory activity will be sufficient (AUC>0.8), we aim to move to the second part of the project. This step focuses on hand-held US machines by gastroenterologists with various levels of IUS experience. Therefore, we aim to examine the accuracy of hand-held US machines for the detection of inflammatory activity by delivering the hand-held US machines to 10 GI specialists who completed the IBUS educational curriculum for IUS (at least module 1+2) with various levels of IUS expertise.

  • Project Goal 1) To examine the capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.
  • Strategy - Comparing various ultrasonographic signs of inflammation acquired by hand-held US machines to that acquired by high-end and premium US machines.
  • Outcomes - Accuracy of hand-held ultrasound machines in the detection of bowel wall inflammatory activity The problem being addressed by the proposed project - Dissemination of IUS is limited due to the high costs of US machines. The use of affordable hand-held US machines for the detection of inflammatory activity will expand the IUS incorporation into the CD diagnosis, monitoring, and treatment approaches, improving patient outcomes.

Significance/Impact The use of affordable and precise US machines will disseminate the use of IUS and expand the IUS incorporation into the diagnosis, monitoring, and treatment of CD, improving patient outcomes

详细描述

• Aim 1. Comparison of the accuracy of hand-held US machines for the detection and measurement of bowel wall inflammatory activity to that of advanced high-end and premium US machines by experienced IUS performers

  • Rationale: IUS use has been incorporated into the processes of diagnosis, follow-up, monitoring, and treatment approaches in CD. One of the limiting factors of IUS dissemination relates to the high costs of the modern high-end and premium US machines used for intestinal ultrasound. Confirming the acceptable accuracy of affordable modern hand-held US machines for detection and measurement of inflammatory activity will enable dissemination of IUS use, as obtaining affordable and precise US machines will be possible.
  • Overall Experimental Strategy and/or Methodology: 150 CD patients will undergo an IUS exam using a hand-held US machine (GE VSCAN air or Philips Lumify) followed by an exam using a high-end or premium US machine (GE S-8, BK 3000 and GE E-9). All exams will be performed by one of 3 experienced IUS performers (DC, AA, HB). The exams will be performed using the same consecutive method with a low-frequency curved array transducer enabling all abdominal quadrants to be examined for fill levels, potential pathological distension, motility, and para-intestinal structures such as abscesses, followed by examination using a high-resolution linear array for detailed examination of the bowel wall structure. All examinations will be performed without any preceding preparation, using a consistent technique and protocol, beginning the examination with the terminal ileum (TI), proximal to the distal colon, followed by an examination of the small bowel. The assessment will be performed for features of inflammation, especially bowel wall thickness of the TI and the colon. Bowel wall thickness will be measured at least in two different areas at a minimal distance of 1 cm from each other. Colonic bowel thickness will be measured at the right, transverse, left, and sigmoid colon. Small bowel wall thickness will be measured at the TI. The thickest measurement of each bowel segment will be chosen as a representative for measurement. Images and cine-loops of each segment of the colon and the TI will be saved on the tablet connected to the hand-held US machine.

Other signs of inflammation will also be examined: Doppler signs within the bowel wall using the modified Limberg scoring system, mesenteric fat hypertrophy, stratification of bowel wall layers and enlargement of lymph nodes.

Intramural and extramural complications including strictures with\without pre-stenotic dilatations, fistulas, and abscesses will be noted and the relative images will be saved.

The findings of different signs of inflammation described will be compared between the hand-held ultrasound and the high-end \ premium US machines. A dichotomic comparison for the presence of each sign (yes/no) will be followed by a comparison of numerical parameters (exact bowel thickness measurement for each segment and Limberg score).

研究设计

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

入排标准

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

入选标准

  • Crohn disease of the terminal ileum and colon- Age> 18

排除标准

  • Pregnancy Inability to visualize he bowel on US Proximal Crohn's disease Proctitis

结局指标

主要结局

The capability and accuracy of hand-held ultrasound machines to detect bowel wall inflammatory activity and complications in CD patients.

时间窗: fro enrollmeent to the end of the study at 2 years

Comparing various ultrasonographic signs of inflammation acquired by hand-held US machines to that acquired by high-end and premium US machines. Defining accuracy of hand-held ultrasound machines in the detection of bowel wall inflammatory activity

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Dan Carter, Gastroenterologist

Head, intestinal ultrasound service

Sheba Medical Center

相似试验