Austrian Registry on Transjugular Intrahepatic Portosystemic Shunts

NCT ID: NCT03409263

Last Updated: 2024-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-28

Study Completion Date

2027-12-31

Brief Summary

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Patients with TIPS will be recruited in this prospective registry study. The clinical course will be documented and biomarkers for prediction of complicatiosn will be assessed.

Detailed Description

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Patients with advanced chronic liver disease may develop portal hypertension, which is the main cause for most complications and deaths of patients with liver cirrhosis. Implantation of a transjugular intrahepatic portosystemic shunt (TIPS) leads to instantaneous alleviation of portal hypertension, but may cause hepatic encephalopathy. Stent grafts, as well as patient stratification and medical surveillance, have drastically improved over the past decades. However, there are few data on long-term outcome after TIPS implantation.This prospective registry study will assess the clinical course of patients after undergoing TIPS intervention and biomarkers for complications after TIPS implantation.

Conditions

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Portal Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Observational study

Not applicable (observational registry study)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-99 years
* Portal hypertension
* Anticipated or past implantation of a transjugular intrahepatic portosystemic shunt (TIPS)
* Informed consent

Exclusion Criteria

* Retraction of consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Austrian Association of Gastroenterology and Hepatology

OTHER

Sponsor Role collaborator

Thomas Reiberger

OTHER

Sponsor Role lead

Responsible Party

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Thomas Reiberger

Univ. Prof. Priv.-Doz. Dr.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas Reiberger, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Thomas Reiberger, MD

Role: CONTACT

+43140400 ext. 47440

Lukas Hartl, MD

Role: CONTACT

+43140400 ext. 65890

Facility Contacts

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Thomas Reiberger, M.D.

Role: primary

+43140400 ext. 47440

Lukas Hartl, M.D.

Role: backup

+43140400 ext. 65890

Mattias Mandorfer, M.D., Ph.D.

Role: backup

Bernhard Scheiner, M.D.

Role: backup

Thomas Reiberger, M.D.

Role: backup

Theresa Bucsics, M.D.

Role: backup

Lukas Hartl, M.D.

Role: backup

Other Identifiers

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AUTIPS 1943/2017

Identifier Type: -

Identifier Source: org_study_id

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