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Trial record 72 of 579 for:    Recruiting, Not yet recruiting, Available Studies | Superior

Normal Range of Superior Mesenteric Artery in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue

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ClinicalTrials.gov Identifier: NCT03937193
Recruitment Status : Recruiting
First Posted : May 3, 2019
Last Update Posted : July 26, 2019
Sponsor:
Collaborator:
North District Hospital
Information provided by (Responsible Party):
Professor Winnie W.C. Chu, Chinese University of Hong Kong

Tracking Information
First Submitted Date May 2, 2019
First Posted Date May 3, 2019
Last Update Posted Date July 26, 2019
Actual Study Start Date July 25, 2019
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 2, 2019)
  • aortomesenteric angle (AMA) [ Time Frame: 2 years ]
    aortomesenteric angle in degree measured on sagittal CT image
  • aortomesenteric distance (AMD) [ Time Frame: 2 years ]
    aortomesenteric distance in millimeter(mm) on axial CT image
  • visceral fat area [ Time Frame: 2 years ]
    visceral fat area in square centimeter(cm2) evaluated by image post-processing software
  • subcutaneous fat area [ Time Frame: 2 years ]
    subcutaneous fat area in square centimeter(cm2) evaluated by image post-processing software
  • area ratio of visceral fat to subcutaneous fat [ Time Frame: 2 years ]
    area ratio in percentage(%)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03937193 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Normal Range of Superior Mesenteric Artery in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
Official Title Normal Range of Superior Mesenteric Artery on Computerized Tomography in Young Chinese Population and Its Correlation With Retroperitoneal Adipose Tissue
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Aortomesenteric Angle
  • Aortomesenteric Distance
  • Retroperitoneal Adipose Tissue
Intervention Diagnostic Test: computerized tomography
abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
Study Groups/Cohorts
  • Non-SMAS group
    subjects in this group are not clinically diagnosed as superior mesenteric artery syndrome(SMAS).
    Intervention: Diagnostic Test: computerized tomography
  • SMAS group
    subjects in this group are clinically diagnosed as superior mesenteric artery syndrome(SMAS).
    Intervention: Diagnostic Test: computerized tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 2, 2019)
510
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 30, 2022
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Chiu Wing CHU, MBChB, MD 3505-2299 winniechu@cuhk.edu.hk
Contact: Kai Ho Yam, MBChB ykh778@ha.org.hk
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03937193
Other Study ID Numbers NTEC-2019-0296
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Professor Winnie W.C. Chu, Chinese University of Hong Kong
Study Sponsor Chinese University of Hong Kong
Collaborators North District Hospital
Investigators
Principal Investigator: Kai Ho Yam, MBChB Department of Radiology, North District Hospital, Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date May 2019