TIPS in Patients With Decompensated Liver Cirrhosis

May 31, 2022 updated by: Hannover Medical School

Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis

This is a single center patient registry of patients receiving a transjugular intrahepatic portosystemic shunt (TIPS) at Hannover Medical School. By collecting and analyzing clinical data as well as blood samples, the overall aim is to optimize TIPS therapy (e.g. specify selection criteria).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Lower Saxony
      • Hannover, Lower Saxony, Germany, 30625
        • Recruiting
        • Hannover Medical School
        • Contact:
        • Principal Investigator:
          • Benjamin Maasoumy, PD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.

Description

Inclusion Criteria:

  • Liver cirrhosis
  • Indication for TIPS insertion
  • Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
  • Informed consent

Exclusion Criteria:

  • Pregnancy or Lactation
  • Age <18 years
  • Lack of Informed consent
  • Symptomatic anemia with Hb <7g/dl

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TIPS insertion
Procedure: TIPS insertion
Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 1 year
Patients who die within 1 year
1 year
Occurrence of (Minimal) Hepatic Encephalopathy
Time Frame: 1 year
Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)
1 year
Change in Nutritional Status
Time Frame: 1 year
Nutritional Status will be measured by hand grip strength (dynamometer) in kg
1 year
Change in Quality of Life
Time Frame: 1 year
Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inflammatory markers (e.g. cytokine)
Time Frame: 12 months
Different cytokines and markers of bacterial translocation (e.g. LPS) are measured
12 months
Change in different metabolites using mass spectroscopy (metabolomics measurements)
Time Frame: 12 months
More than 300 metabolites will be measured
12 months
Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)
Time Frame: 12 months
Fluorescence activated cell sorting (FACS) analysis, genetics and in vitro stimulation assays will be performed
12 months
Analysis of stool samples
Time Frame: 12 months
Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)
12 months
Measurement of portal hypertension
Time Frame: 6 months
Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Benjamin Maasoumy, PD, Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 29, 2019

Primary Completion (ANTICIPATED)

December 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (ACTUAL)

March 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BM_84982019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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