Clinical Trials Directory

Trials / Completed

CompletedNCT03459378

Outcome After TIPS

Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)

Status
Completed
Phase
Study type
Observational
Enrollment
158 (actual)
Sponsor
Medical University of Graz · Academic / Other
Sex
All
Age
18 Years – 100 Years
Healthy volunteers
Not accepted

Summary

This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.

Detailed description

The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. It can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger. However, this invasive procedure carries a high risk for complications. 30-days mortality after TIPS implantation amounts between 4% and 45%. A common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after TIPS implantation. Other complications that are directly related to the intervention are bleeding, infections and stent migration. Aim of this retrospective single centre study is to investigate the long-term outcome after TIPS implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy. Intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against TIPS.

Conditions

Interventions

TypeNameDescription
OTHERno intervention - retrospective analysesretrospective data examination, there are no study related interventions

Timeline

Start date
2018-03-23
Primary completion
2019-03-01
Completion
2020-05-14
First posted
2018-03-08
Last updated
2020-05-15

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03459378. Inclusion in this directory is not an endorsement.