Outcome After TIPS

Sponsor
Medical University of Graz (Other)
Overall Status
Completed
CT.gov ID
NCT03459378
Collaborator
(none)
158
1
25.7
6.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention - retrospective analyses

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 Design

Study Type:
Observational
Actual Enrollment :
158 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
Actual Study Start Date :
Mar 23, 2018
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
May 14, 2020

Outcome Measures

Primary Outcome Measures

  1. transplantation free survival [from date of TIPS until the event, up to 4 years]

    Survival without liver Transplantation in days

Secondary Outcome Measures

  1. 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

  2. occurrence of ascites [from date of TIPS until the event, up to 4 years]

    time to (re)occurrence of ascites in days

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medical University of Graz Graz Austria 8010

Sponsors and Collaborators

  • Medical University of Graz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT03459378
Other Study ID Numbers:
  • Retro-TIPS
First Posted:
Mar 8, 2018
Last Update Posted:
May 15, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 15, 2020