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TIPS in Patients With Decompensated Liver Cirrhosis

ConditionDecompensated Liver Cirrhosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorHannover Medical School

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Liver cirrhosis

Indication for TIPS insertion

Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School

Informed consent

Disqualifiers

Pregnancy or Lactation

Age <18 years

Lack of Informed consent

Symptomatic anemia with Hb <7g/dl

Trial population

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

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • TIPS insertion

    Procedure/Surgery

    Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: TIPS insertion1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Patients who die within 1 year

Time frame
1 year
2

Occurrence of (Minimal) Hepatic Encephalopathy

Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)

Time frame
1 year
3

Change in Nutritional Status

Nutritional Status will be measured by hand grip strength (dynamometer) in kg

Time frame
1 year
4

Change in Quality of Life

Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)

Time frame
1 year

Secondary outcomes

1

Change in inflammatory markers (e.g. cytokine)

Different cytokines and markers of bacterial translocation (e.g. LPS) are measured

Time frame
12 months
2

Change in different metabolites using mass spectroscopy (metabolomics measurements)

More than 300 metabolites will be measured

Time frame
12 months
3

Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs)

Fluorescence activated cell sorting (FACS) analysis, genetics and in vitro stimulation assays will be performed

Time frame
12 months
4

Analysis of stool samples

Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hannover Medical School

Lead sponsor

Source ClinicalTrials.gov
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