Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS (TIPS-SWE)

March 2, 2017 updated by: Jonel Trebicka
The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.

Study Type

Observational

Enrollment (Actual)

83

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

This prospective multicentre study included patients, which underwent TIPS insertion and had reliable SWE or TE measurement of the liver before TIPS.

Description

Inclusion Criteria:

  • TIPS insertion and had reliable SWE or TE measurement

Exclusion Criteria:

  • contraindication for TIPS
  • no reliable SWE or TE measurement

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
1
receiving TE before and 30 min after TIPS
Diagnostic test: Stiffness measurement
Transient Elastopgraphy (TE) or Shear-Wave-Elastography
2
receiving SWE before and 7 days, 6 weeks and 3 months after TIPS
Diagnostic test: Stiffness measurement
Transient Elastopgraphy (TE) or Shear-Wave-Elastography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Acute-on-chronic Lvier failure
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Jonel Trebicka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 1, 2013

Primary Completion (Actual)

November 30, 2015

Study Completion (Actual)

February 29, 2016

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (Actual)

March 7, 2017

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 2, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIPS-SWE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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