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

August 28, 2018 updated by: Xiao Li, West China Hospital
To prospectively investigate the effect of transjugular intrahepatic portosystemic shunt (TIPS) on oxygenation in cirrhotic patients with hepatopulmonary syndrome (HPS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
HPS-TIPS group
Procedure: Transjugular intrahepatic portosystemic shunt

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

May 22, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 28, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WCH-2014-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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