TIPS in Patients With Decompensated Liver Cirrhosis

Sponsor

Hannover Medical School (Other)

Overall Status

Recruiting

CT.gov ID

NCT04801290

Collaborator

(none)

250

Enrollment

Location

63.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Decompensated Liver Cirrhosis	Procedure: TIPS insertion

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 29, 2019

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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