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
Multicenter, prospective, observational research project on children aged from 10 to 15 years old undergoing abdominal ultrasound examinations during routine clinical practice.
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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Imaging Institute of Southern Switzerland | Bellinzona | |
Switzerland | Hôpitaux Universitaires Genève | Geneva |
Lead Sponsor | Collaborator |
---|---|
Ente Ospedaliero Cantonale, Bellinzona | Imaging Institute of Southern Switzerland |
Switzerland,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03416647 -
SMAS: a Prospective Study in a Single Institution
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N/A |