Outcome After TIPS

Completed

• Conditions: Liver Cirrhosis; Hypertension, Portal; Variceal Hemorrhage; Ascites Hepatic

• Registration Number: NCT03459378
• Lead Sponsor: Medical University of Graz

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-26
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-08
• Study Start: 2018-03-23
• Primary Completion: 2019-03-01
• Status Verified: 2020-05
• Study Completion: 2020-05-14
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
transplantation free survival	from date of TIPS until the event, up to 4 years	Survival without liver Transplantation in days

Secondary Outcome Measures

Name	Time	Method
occurrence of hepatic encephalopathy	from date of TIPS until the event, up to 4 years	time to occurrence of the first episode of hepatic encephalopathy in days
occurrence of ascites	from date of TIPS until the event, up to 4 years	time to (re)occurrence of ascites in days

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria