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Completed

NCT Number: NCT03459378

Outcome After TIPS

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.

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Key information

Conditions

Hypertension, Portal Ascites Hepatic Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Variceal Hemorrhage

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Graz

Graz, 8010, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017

Exclusion criteria

  • age under 18

Treatment and study plan

no intervention - retrospective analyses

Other

retrospective data examination, there are no study related interventions

Primary outcomes

  1. transplantation free survival

    Time frame: from date of TIPS until the event, up to 4 years

    Survival without liver Transplantation in days

Secondary outcomes

  1. occurrence of hepatic encephalopathy

    Time frame: from date of TIPS until the event, up to 4 years

    time to occurrence of the first episode of hepatic encephalopathy in days

  2. occurrence of ascites

    Time frame: from date of TIPS until the event, up to 4 years

    time to (re)occurrence of ascites in days

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Mar 8, 2018
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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