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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
      • Hong Kong, China
        • Department of Radiology， North District Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Non-SMAS group
subjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS).
Diagnostic test: computerized tomography
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
SMAS group
subjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS).
Diagnostic test: computerized tomography
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
aortomesenteric angle (AMA)
Time Frame: 2 years
aortomesenteric angle in degree measured on sagittal CT image
2 years
aortomesenteric distance (AMD)
Time Frame: 2 years
aortomesenteric distance in millimeter(mm) on axial CT image
2 years
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
2 years
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North District Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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