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NCT01252043 Clinical Trial

Retrospective Review of CT and MR in Pediatric Patients With Cholestasis

Children Clinical Trial

Official title:
Retrospective Review of Computed Tomography and Magnetic Resonance Images in Pediatric Patients With Cholestasis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01252043
Other study ID # 201010044R
Secondary ID
Status Recruiting
Phase N/A
First received November 25, 2010
Last updated November 30, 2010
Start date October 2010
Est. completion date October 2011

Study information
Verified date November 2010
Source National Taiwan University Hospital
Contact Steven SF Peng, M.D.
Phone 886-2-23123456
Email sfpeng@ntuh.gov.tw
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary esophageal variceal bleeding retrospective review No
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