Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population

Superior Mesenteric Artery Syndrome Clinical Trial

Official title:

A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515251
• Other study ID #: RAD-SMA-001
• Status: Recruiting
• Start date: April 27, 2020
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Marirosa Cristallo Lacalamita, MD
• Phone: +41 (0)91 811 84 75
• Email: Marirosa.CristalloLacalamita[@]eoc.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.

Description:

Demographics data, clinical indications, ultrasound diagnosis, and ultrasound measurements will be recorded and stored on an database. Ultrasound measurements will be analyzed to define the normal range of values of Superior Mesenteric Artery (SMA) angle and Superior Mesenteric Artery - Aorta (SMA-A) distance in the pediatric population according to age, Body Mass Index (BMI), and fat parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 289
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• Male and female children
• Age ranging from10 to 15 years, included
• Abdominal ultrasound examination to be performed for indications other than gastrointestinal evaluation
• Signed Informed Consent

Exclusion Criteria:

• Presence of a disease that could distort the anatomy around the SMA (e.g., abdominal mass, lymphadenopathy, severe scoliosis, free abdominal fluid)
• Oncologic patients at risk of neoplastic cachexia.

Related Conditions & MeSH terms

• Mesenteric Ischemia
• Superior Mesenteric Artery Syndrome

Intervention

Diagnostic Test:
• Ultrasound measurements
ultrasound measurement at the level of the left renal vein on a sagittal plane according to age

Locations

Country	Name	City	State
Switzerland	Imaging Institute of Southern Switzerland	Bellinzona
Switzerland	Hôpitaux Universitaires Genève	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona	Imaging Institute of Southern Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define the normal range of values of the SMA angle	Measurement in degree with its 95% confidence interval	1 day
Secondary	Define the normal range of values of the SMA-A distance LV	Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination at the level of the left renal vein on an axial plane according to age	1 day
Secondary	Define the normal range of values of the SMA-A distance D	Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination at a level where the third part of the duodenum crosses on an axial plane according to age	1 day
Secondary	Define the normal range of values of the SMA angle (degree), SMA-A distance LV	Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination according to BMI categories, subcutaneous and visceral fat thickness	1 day
Secondary	Assess the association between the SMA angle and BMI categories	According to age and sex.	1 day