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NCT Number: NCT04515251

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.

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Key information

Conditions

Superior Mesenteric Artery Syndrome Digestive System Diseases Duodenal Diseases Duodenal Obstruction Gastrointestinal Diseases Intestinal Diseases

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imaging Institute of Southern Switzerland, Bellinzona, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound measurements

Diagnostic Test

ultrasound measurement at the level of the left renal vein on a sagittal plane according to age

Primary outcomes

  1. Define the normal range of values of the SMA angle

    Time frame: 1 day

    Measurement in degree with its 95% confidence interval

Secondary outcomes

  1. Define the normal range of values of the SMA-A distance LV

    Time frame: 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

  2. Define the normal range of values of the SMA-A distance D

    Time frame: 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

  3. Define the normal range of values of the SMA angle (degree), SMA-A distance LV

    Time frame: 1 day

    Measurement in millimeter (mm) with its 95% confidence interval measured through ultrasound examination according to BMI categories, subcutaneous and visceral fat thickness

  4. Assess the association between the SMA angle and BMI categories

    Time frame: 1 day

    According to age and sex.

Study contacts

Contact information is provided by the study sponsor or research team.

Marirosa Cristallo Lacalamita, MD

CONTACT

[email protected]

+41 (0)91 811 84 75

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Other

Collaborators

  • Imaging Institute of Southern Switzerland

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2020
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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