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

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

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

Study Overview

• Status: Recruiting
• Conditions: Superior Mesenteric Artery Syndrome
• Intervention / Treatment: Diagnostic test: Ultrasound measurements

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 289

Contacts and Locations

• Study Contact: Name: Marirosa Cristallo Lacalamita, MD; Phone Number: +41 (0)91 811 84 75; Email: Marirosa.CristalloLacalamita@eoc.ch

Study Locations

• Switzerland
  • Bellinzona, Switzerland, 6500
    • Recruiting
    • Imaging Institute of Southern Switzerland
    • Contact: Marirosa Cristallo Lacalamita, MD; Phone Number: +41 (0)91 811 84 75; Email: Marirosa.CristalloLacalamita@eoc.ch
  • Geneva, Switzerland, 1205
    • Recruiting
    • Hôpitaux Universitaires Genève
    • Contact: Sylviane Hanquinet, Prof; Phone Number: +41 (0)22 372 70 36; Email: Sylviane.Hanquinet-Ginter@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children aged from 10 to 15 years

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the normal range of values of the SMA angle	Measurement in degree with its 95% confidence interval	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Assess the association between the SMA angle and BMI categories	According to age and sex.	1 day

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Collaborators: Imaging Institute of Southern Switzerland
• Investigators: Principal Investigator: Marirosa Cristallo Lacalamita, MD, Imaging Institute of Southern Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2020
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 13, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 17, 2020

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Gastrointestinal Diseases; Intestinal Diseases; Duodenal Diseases; Duodenal Obstruction; Mesenteric Ischemia; Superior Mesenteric Artery Syndrome
• Other Study ID Numbers: RAD-SMA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No