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

Recruiting

• Conditions: Superior Mesenteric Artery Syndrome

• Registration Number: NCT04515251
• Lead Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Brief Summary

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

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 Timeline

• Study Start: 2020-04-27
• Study First Submitted: 2020-08-13
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-17
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2024-06-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 289

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Define the normal range of values of the SMA angle	1 day	Measurement in degree with its 95% confidence interval

Secondary Outcome Measures

Name	Time	Method
Define the normal range of values of the SMA-A distance D	1 day	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
Define the normal range of values of the SMA-A distance LV	1 day	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
Define the normal range of values of the SMA angle (degree), SMA-A distance LV	1 day	Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination according to BMI categories, subcutaneous and visceral fat thickness
Assess the association between the SMA angle and BMI categories	1 day	According to age and sex.

Trial Locations

Locations (2)

Imaging Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Hôpitaux Universitaires Genève; 🇨🇭 Geneva, Switzerland