NCT03937193

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
510

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 25, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

May 2, 2019

Last Update Submit

May 17, 2022

Conditions

Aortomesenteric AngleAortomesenteric DistanceRetroperitoneal Adipose Tissue

Keywords

aortomesenteric angleaortomesenteric distanceretroperitoneal adipose tissuecomputerized tomographyyoung Chinese population

Outcome Measures

Primary Outcomes (5)

  • aortomesenteric angle (AMA)

    aortomesenteric angle in degree measured on sagittal CT image

    2 years

  • aortomesenteric distance (AMD)

    aortomesenteric distance in millimeter(mm) on axial CT image

    2 years

  • visceral fat area

    visceral fat area in square centimeter(cm2) evaluated by image post-processing software

    2 years

  • subcutaneous fat area

    subcutaneous fat area in square centimeter(cm2) evaluated by image post-processing software

    2 years

  • area ratio of visceral fat to subcutaneous fat

    area ratio in percentage(%)

    2 years

Study Arms (2)

Non-SMAS group

subjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS).

Diagnostic Test: computerized tomography

SMAS group

subjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS).

Diagnostic Test: computerized tomography

Interventions

computerized tomographyDIAGNOSTIC_TEST

abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.

Non-SMAS groupSMAS group

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability 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).

You may qualify if:

  • With age range of 10-35 years old.
  • Chinese ethnicity.
  • With abdomen contrast CT.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology， North District Hospital

Hong Kong, China

Location

MeSH Terms

Interventions

Tomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Kai Ho Yam, MBChB

    Department of Radiology, North District Hospital, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 2, 2019

First Posted

May 3, 2019

Study Start

July 25, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)