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NCT03072615 Clinical Trial

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

Portal Hypertension Clinical Trial

— TIPS-SWE  

Official title:
Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03072615
Other study ID # TIPS-SWE
Secondary ID
Status Completed
Phase N/A
First received March 2, 2017
Last updated March 2, 2017
Start date April 1, 2013
Est. completion date February 29, 2016

Study information
Verified date March 2017
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 83
Est. completion date February 29, 2016
Est. primary completion date November 30, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- TIPS insertion and had reliable SWE or TE measurement

Exclusion Criteria:

- contraindication for TIPS

- no reliable SWE or TE measurement

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Stiffness measurement
Transient Elastopgraphy (TE) or Shear-Wave-Elastography

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Jonel Trebicka

Outcome
Type Measure Description Time frame Safety issue
Primary Survival 3 months
Secondary Acute-on-chronic Lvier failure 3 months
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