Outcome After TIPS

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459378
• Other study ID #: Retro-TIPS
• Status: Completed
• Start date: March 23, 2018
• Est. completion date: May 14, 2020

Study information

• Verified date: May 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: May 14, 2020
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Ascites
• Ascites Hepatic
• Hemorrhage
• Hypertension, Portal
• Liver Cirrhosis
• Variceal Hemorrhage

Intervention

Other:
• no intervention - retrospective analyses
retrospective data examination, there are no study related interventions

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transplantation free survival	Survival without liver Transplantation in days	from date of TIPS until the event, up to 4 years
Secondary	occurrence of hepatic encephalopathy	time to occurrence of the first episode of hepatic encephalopathy in days	from date of TIPS until the event, up to 4 years
Secondary	occurrence of ascites	time to (re)occurrence of ascites in days	from date of TIPS until the event, up to 4 years