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Retrospective Review of CT and MR in Pediatric Patients With Cholestasis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01252043
First Posted: December 2, 2010
Last Update Posted: December 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and the measurement of transverse diameters of paraesophageal and gastroesophageal veins.

Condition
Cholestasis Children

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Retrospective Review of Computed Tomography and Magnetic Resonance Images in Pediatric Patients With Cholestasis

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • esophageal variceal bleeding [ Time Frame: retrospective review ]

Estimated Enrollment: 80
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
cohort
cholestatic children without esophageal variceal bleeding
study
cholestatic children with esophageal variceal bleeding
cholestatic children without EV
cholestatic children without esophageal variceal bleeding

Detailed Description:

We intend to review retrospectively 80 pediatric patients on an average of 2 years, who underwent 64-slice CT or MR examinations between January 2005 and Oct 2010 and had EVs on esophagogastroduodenoscopy. Splenic diameters (mm) and hepatic diameters of all patients were measured. Splenic and hepatic volume indices also calculated. The transverse diameters of paraesophageal varices (PVs) and perigastric varices (PGVs) were measured adjacent to the lower thoracic esophagus and within the lesser sac, respectively.

We will try to find out the possible splenic, hepatic or vascular predicting factors useful to evaluate the risk of clinically evident esophageal varices.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
younger than 18 years of age
Criteria

Inclusion Criteria:

  • all cholestatic children with CT, MR and complete medical record

Exclusion Criteria:

  • all cholestatic children without either CT, MR or complete medical record
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252043


Contacts
Contact: Steven SF Peng, M.D. 886-2-23123456 ext 66887 sfpeng@ntuh.gov.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Steven Peng, M.D.    886-2-23123456    sfpeng@ntuh.gov.tw   
Principal Investigator: Steven Peng, M.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Chair: Tiffany TF Shih, M.D. Department of Medical Imaging, National Taiwan University Hospital
  More Information

Responsible Party: Steven Shinn-Forng Peng, staff of Department of Medical Imaging, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01252043     History of Changes
Other Study ID Numbers: 201010044R
First Submitted: November 25, 2010
First Posted: December 2, 2010
Last Update Posted: December 2, 2010
Last Verified: November 2010

Keywords provided by National Taiwan University Hospital:
cholestasis
children

Additional relevant MeSH terms:
Cholestasis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases