The Utility of Hand-held Ultrasound Devices to Detect Bowel Wall Inflammatory Activity in Crohn's Disease
Conditions: Crohn Disease (CD)
Sponsor: Sheba Medical Center

Protocol 0523-23-SMC version 2.0 dated 07-April-2024
 
The precision of hand-held ultrasound machines for the diagnosis of 
bowel inflammation in intestinal ultrasound  
NCT SHEBA-23-0523-DC-CTIL 
Date 11.11.24 

Protocol 0523-23-SMC version 2.0 dated 07-April-2024
 
Introduction 
Technological advances in the field of ultrasonography and the growing experience of 
ultra-sonographers have contributed to the advent of ultrasound as a clinically 
important, noninvasive imaging modality in inflammatory bowel disease (IBD). High-
resolution assessment of the bowel layers as well as visualization of possible 
intestinal and extraintestinal pathologies (such as stenosis, abscesses, or fistulas) can 
be attained plainly using intestinal ultrasound (IUS). 
 Intestinal ultrasound can be used for the initial evaluation and follow-up of patients 
with clinically suspected IBD. Thickening of the bowel wall is the most significant 
ultrasonographic feature of Crohn’s disease (CD) and is found to be a valid marker of 
inflammation in CD.  Transmural remission of the small and large bowel is defined by 
bowel wall thickness (BWT) ≤3 mm. Other ultrasonographic signs of active disease 
including pseudo stratification of the bowel wall, mesenteric and adipose 
hypertrophy, enlargement of lymph nodes, and enhancement of blood flow in the 
bowel wall. 
One of the major obstacles in implementing intestinal ultrasound services for IBD 
patients is the costs related to ultrasound machines.  The costs of the mid-range (and 
higher levels of quality) ultrasound machine are considerable, and although large 
medical centers in developed countries can obtain ultrasound machines, smaller 
centers and centers in undeveloped countries may struggle with the cost of the 
machines. The inability to perform a point-of-care intestinal ultrasound impedes IBD 
patients' medical treatment.  
Recently, some large US companies (such as GE and Philips) developed new models 
of hand-held small ultrasound machines. Those machines are affordable, and if their 
quality will be proven to be good enough for the detection of bowel inflammation 
and complication, the use of intestinal ultrasound can potentially increase, allowing 
better care for IBD patients.   
Our idea is to compare the quality of hand-held US machines and that of mid-range 
and high-end US machines for the detection of bowel wall inflammation in IBD. 
Methods 

Protocol 0523-23-SMC version 2.0 dated 07-April-2024
 
The project will examine the precision of 2 different handheld US machines (GE 
VSCAN air and Philips Lumify) for the detection of bowel inflammation and 
complication in Crohn's disease patients. 
Study population 
The study population will include 150 consecutive Crohn's patients undergoing 
intestinal ultrasound exams at the discretion of their treating physician. 
All patients will go through an examination by a hand-held ultrasound machine. All 
exams will be followed by a high-end ultrasound machine (GE-S8 OR GE-E9) by the 
same performer. 
Intestinal ultrasound 
All exams will be performed using the same method: starting with a low-frequency 
curved array transducer, followed by examination using a high-resolution linear array 
transducer. All examinations will be performed without any preceding preparation, 
using a consistent technique and protocol, beginning the examination with the 
terminal ileum and the proximal to distal colon, followed by a complete examination 
of the small bowel. Assessment will be performed for features of inflammation, 
especially bowel wall thickness (>3 mm). Bowel walls thickness ≤3 mm is significantly 
associated with endoscopic and transmural remission, as measured by magnetic 
resonance imaging and normal C-reactive protein levels.  
Comparison will include the ability to imagine each bowel segment (rectum, sigmoid 
colon, left colon, transverse colon, right colon, terminal ileum, and other small bowel 
segments) by each ultrasound machine type using convex and linear transducers. 
Other parameters to be reported and compared between machines will include: 
1. Bowel wall thickness of each segment (numerical in mm) 
2. Disappearance of bowel wall layers (pseudosratification) (Y/N) 
3. Blood flow within the bowel wall (as described by the Limberg score 0-3) 
4. Mesenteric fat hypertrophy (Y/N/Uncertain) 
5. Lymph node enlargement (Y/N, maximal size) 
6. Complications: stricture, fistula abscess (Y/N) 

Protocol 0523-23-SMC version 2.0 dated 07-April-2024
 
Each patient will go through 2 exams- one using the handheld machine and the other 
using the regular machines. Images and cineloops of each segment in transverse and 
cross sectional planes will be stored in the ultrasound (handheld and high 
end\premium) for further re-evaluation. All images will be anonymized automatically 
or by cropping the metadata. 
The images will be coded by the study coordinator and will be stored in 3 different 
places: A hospital computer, the study coordinator's computer and in a cloud drive. 
Only the investigators and the study coordinator will have permissions to access the 
stored data. 
Images and cineloops from each segment will be stored (see later) and re-evaluated 
by one of the other investigators for signs of inflammation as described earlier. 
 The ultrasonographic finding on the high-end ultrasound machine (GE S8) will be 
regarded as the gold standard for comparison with the other types of ultrasound 
machines.  
Inclusion criteria: 
1. Age>18 
2. Previously known or suspected Crohn's disease. 
3. BMI< 30. 
Exclusion criteria 
1. Any kind of stoma. 
2. Inability to demonstrate any bowel segment using the gold standard high-end 
ultrasound machine. 
3. Pregnancy. 
Hand-held US machines evaluation 
Prior to the initiation of the study, each investigator will perform 20 exams on each of 
the hand held machines as a learning curve phase. 

Protocol 0523-23-SMC version 2.0 dated 07-April-2024
 
The ease of the operation of each system and the overall satisfaction for the use of 
each machine will be graded after each exam by all investigators using a lickert scale 
of 0 to 10 
 
Primary outcome 
1. The capability to imagine each bowel segment (rectum, sigmoid colon, left 
colon, transverse colon, right colon, terminal ileum, and other small bowel 
segments) using hand-held and mid-range ultrasound machines type using 
convex and linear transducers. 
2. The capability to detect bowel wall thickening using hand-held and mid-range 
ultrasound machines type using convex and linear transducers. 
Secondary outcomes 
1. The accuracy of bowel wall thickness measurements using hand-held US and 
mid-range US machines when compared to the gold standard. 
2. The capability to detect other signs of inflammation using hand-held US and 
mid-range US machines when compared to the gold standard, including: 
i. 
Disappearance of bowel wall layers (pseudosratification) (Y/N) 
ii. 
Blood flow within the bowel wall (as described by the Limberg score 0- 
iii. 
Mesenteric fat hypertrophy (Y/N/Uncertain) 
iv. 
Lymph node enlargement (Y/N, maximal size) 
3. The capability to detect complications (stricture, fistula and abscess) using 
hand-held US and mid-range US machines when compared to the gold 
standard. 
 
Data management: 
All images will be anonymized automatically or by cropping the metadata. 
The images will be coded by the study coordinator and will be stored in 3 
different places: A hospital computer, the study coordinator's computer and in a 
cloud drive. Only the investigators and the study coordinator will have 
permissions to access the stored data. 
 
 
 
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