Retrospective Review of CT and MR in Pediatric Patients W... | NCT01252043

Studies
Retrospective Review of CT and MR in Pediatric Patients With Cholestasis

NCT01252043

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Dec 2, 2010Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Cholestasis
Children

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Oct 2011Estimated

Completion Date

Oct 2011Estimated

First Submitted Date

Nov 25, 2010

First Submission Date that Met QC Criteria

Nov 30, 2010

First Posted Date

Dec 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2010

Last Update Posted Date

Dec 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort		cholestatic children without esophageal variceal bleeding
study		cholestatic children with esophageal variceal bleeding
cholestatic children without EV		cholestatic children without esophageal variceal bleeding

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
esophageal variceal bleeding		retrospective review

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

younger than 18 years of age

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Steven SF Peng, M.D.	Contact	886-2-23123456	66887	sfpeng@ntuh.gov.tw

Overall Officials

Name	Affiliation	Role
Tiffany TF Shih, M.D.	Department of Medical Imaging, National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D002779	Cholestasis

Ancestor Terms

ID	Term
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided