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

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ClinicalTrials.gov Identifier: NCT04515251
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : August 25, 2021
Sponsor:
Collaborator:
Imaging Institute of Southern Switzerland
Information provided by (Responsible Party):
Marirosa Cristallo Lacalamita, Ente Ospedaliero Cantonale, Bellinzona

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

Condition or disease Intervention/treatment
Superior Mesenteric Artery Syndrome 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 Design
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Study Type : Observational
Estimated Enrollment : 289 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective, Observational, Multicenter Study on Ultrasound Evaluation of Superior Mesenteric Artery Measurements in a Healthy Pediatric Population
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : May 31, 2022
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. Define the normal range of values of the SMA angle [ Time Frame: 1 day ]
    Measurement in degree with its 95% confidence interval


Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children aged from 10 to 15 years
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515251


Contacts
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Contact: Marirosa Cristallo Lacalamita, MD +41 (0)91 811 84 75 Marirosa.CristalloLacalamita@eoc.ch

Locations
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Switzerland
Imaging Institute of Southern Switzerland Recruiting
Bellinzona, Switzerland, 6500
Contact: Marirosa Cristallo Lacalamita, MD    +41 (0)91 811 84 75    Marirosa.CristalloLacalamita@eoc.ch   
Hôpitaux Universitaires Genève Recruiting
Geneva, Switzerland, 1205
Contact: Sylviane Hanquinet, Prof    +41 (0)22 372 70 36    Sylviane.Hanquinet-Ginter@hcuge.ch   
Sponsors and Collaborators
Ente Ospedaliero Cantonale, Bellinzona
Imaging Institute of Southern Switzerland
Investigators
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Principal Investigator: Marirosa Cristallo Lacalamita, MD Imaging Institute of Southern Switzerland
More Information
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Responsible Party: Marirosa Cristallo Lacalamita, MD Principal investigator, Ente Ospedaliero Cantonale, Bellinzona
ClinicalTrials.gov Identifier: NCT04515251    
Other Study ID Numbers: RAD-SMA-001
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: August 25, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mesenteric Ischemia
Superior Mesenteric Artery Syndrome
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Peritoneal Diseases
Vascular Diseases
Cardiovascular Diseases
Duodenal Obstruction
Duodenal Diseases