the Correlation Between Non-invasive Indicators in Patien... | NCT02848573

Studies
the Correlation Between Non-invasive Indicators in Patients With Biliary Atresia

NCT02848573

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jul 28, 2016Estimated

Enrollment

41Actual

Phase

Not provided

Conditions

to Find Out Non-invasive Indices to Predict the Status of Hepatic Fibrosis in BA Patients.

Interventions

Not provided

Countries

Not provided

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

Jul 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Jun 2016Actual

Completion Date

Not provided

First Submitted Date

Jul 26, 2016

First Submission Date that Met QC Criteria

Jul 26, 2016

First Posted Date

Jul 28, 2016Estimated

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

Jul 26, 2016

Last Update Posted Date

Jul 28, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

National Taiwan University Hospital, Assistant Professor, National Taiwan University HospitalPrincipal Investigator

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

we propose this study and try to find out possible clinical applicable non-invasive imaging indices or its combination with the laboratory indices to predict the status of hepatic fibrosis in BA patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

41Actual

Measure	Description	Time Frame
pathologic METAVIR fibrosis score		1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

pathological proved diagnosis of biliary atresia, and without other distinct abnormality or malformations. All had undergone Kasai portoenterostomy. All of them received abdominal MRI study.

Exclusion Criteria:

absence of laboratory data required.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Days

Maximum Age

30 Years

Standard Ages

ChildAdult

Study Population

biliary atresia

Sampling Method

Non-Probability Sample