- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03937193
Normal Range of Superior Mesenteric Artery in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
May 17, 2022 updated by: Professor Winnie W.C. Chu, Chinese University of Hong Kong
Normal Range of Superior Mesenteric Artery on Computerized Tomography in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
In literature, superior mesenteric artery (SMA) angle, also named as aortomesenteric angle (AMA), varies greatly in both adult and children; while the aortomesenteric distance also ranges widely.
Both AMA and AMD are influenced by retroperitoneal fat.
Decrease of AMA and AMD may lead to the superior mesenteric artery syndrome(SMAS), which is a rare medical condition mainly presenting with duodenum obstruction.
To our knowledge, normal range of AMA and AMD in local young Chinese population remain unclear; on the other hand, there have only a few studies exploring the relationship between them.
This project proposes to establish the normal range of AMA and AMD in local young Chinese population, and to further investigate how the retroperitoneal adipose tissue correlates with AMA and AMD.
The normal range obtained in this proposed study will provide more specific reference value to distinguish abnormal AMA and AMD, and to improve the diagnosis accuracy of SMAS in local population.
Moreover, this study will provide deeper insight concerning the impact of retroperitoneal fat on AMA and AMD.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
510
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, China
- Department of Radiology, North District Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 35 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The investigators will retrospectively recruit individuals from the local population who had undergone abdomen contrast CT scans within hospitals in the New Territories East Cluster (NTEC) of Hong Kong for both emergency and elective purposes in the year 2013-2019.
Total sample will comprise two groups: (1) Non-SMAS Group (N=500); and (2) SMAS group (N=10).
Description
Inclusion Criteria:
- With age range of 10-35 years old.
- Chinese ethnicity.
- With abdomen contrast CT.
Exclusion Criteria:
- Any patients with diagnosis of SMAS will be excluded from the Non-SMAS group.
- Patients who had undergone more than one CT scan during the research period.
- Previous retroperitoneal, abdominal surgery.
- Conditions causing significant weight loss, e.g. anorexia nervosa, malabsorption.
- Presence of abdominal masses or pathology that will affect the anatomy of aorta- superior mesenteric artery and the retroperitoneal structures.
- Presence of severe scoliosis and/or history of spinal fixation that may increase incidence of SMA syndrome.
- Presence of free intraperitoneal or retroperitoneal fluid that may affect fat measurement, e.g. following trauma, or ascites.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Ecologic or Community
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Non-SMAS group
subjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS).
|
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
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|
SMAS group
subjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS).
|
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
aortomesenteric angle (AMA)
Time Frame: 2 years
|
aortomesenteric angle in degree measured on sagittal CT image
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2 years
|
|
aortomesenteric distance (AMD)
Time Frame: 2 years
|
aortomesenteric distance in millimeter(mm) on axial CT image
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2 years
|
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visceral fat area
Time Frame: 2 years
|
visceral fat area in square centimeter(cm2) evaluated by image post-processing software
|
2 years
|
|
subcutaneous fat area
Time Frame: 2 years
|
subcutaneous fat area in square centimeter(cm2) evaluated by image post-processing software
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2 years
|
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area ratio of visceral fat to subcutaneous fat
Time Frame: 2 years
|
area ratio in percentage(%)
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Kai Ho Yam, MBChB, Department of Radiology, North District Hospital, Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
May 2, 2019
First Submitted That Met QC Criteria
May 2, 2019
First Posted (Actual)
May 3, 2019
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 17, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019.310
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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