Effect of Transjugular Intrahepatic Portosystemic Shunt o... | NCT02148536

Studies
Effect of Transjugular Intrahepatic Portosystemic Shunt on Oxygenation in Cirrhotic Patients With Hepatopulmonary Syndrome

NCT02148536

Sponsor

West China Hospital

Status

Completed

Last Update Posted

Aug 31, 2018Actual

Enrollment

64Actual

Phase

Not provided

Conditions

Hepatopulmonary Syndrome

Interventions

Transjugular intrahepatic portosystemic shunt

Countries

China

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

Aug 2018

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

Jun 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

May 21, 2014

First Submission Date that Met QC Criteria

May 22, 2014

First Posted Date

May 28, 2014Estimated

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

Aug 28, 2018

Last Update Posted Date

Aug 31, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).

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

Retention

Enrollment

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HPS-TIPS group			Procedure: Transjugular intrahepatic portosystemic shunt

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transjugular intrahepatic portosystemic shunt	Procedure		HPS-TIPS group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alveolar-arterial oxygen gradient (PA-a,O2)		12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Macroaggregated albumin (MAA) shunt fraction		12 Weeks
Exhaled nitric oxide (eNO)		12 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presence of cirrhosis
Alveolar-arterial oxygen gradient ≥ 15 mm Hg (≥ 20 mm Hg for age > 64 years)
Positive contrast-enhanced echocardiography

Exclusion Criteria:

Age of less than 18 years
Intrinsic cardiopulmonary disease
Malignancy
Active infection
Pregnancy
Previous shunt therapy
Refusal to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Cirrhotic patients with hepatopulmonary syndrome undergoing transjugular intrahepatic portosystemic shunt for any indication at West China Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital, Sichuan university		Chengdu	Sichuan	610041	China

Condition Browse Module

MeSH Terms

ID	Term
D020065	Hepatopulmonary Syndrome

Ancestor Terms

ID	Term
D008107	Liver Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019168	Portasystemic Shunt, Transjugular Intrahepatic

Ancestor Terms

ID	Term
D011170	Portasystemic Shunt, Surgical
D000714	Anastomosis, Surgical
D013514	Surgical Procedures, Operative
D058017	Vascular Grafting

Browse Leaves

Not provided

Browse Branches

Not provided