TIPS in Patients With Decompensated Liver Cirrhosis

Recruiting

• Conditions: Decompensated Liver Cirrhosis
• Interventions: Procedure: TIPS insertion

• Registration Number: NCT04801290
• Lead Sponsor: Hannover Medical School

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-29
• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-17
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-31
• Last Update Posted: 2022-06-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TIPS insertion	TIPS insertion	-

Primary Outcome Measures

Name	Time	Method
Change in Nutritional Status	1 year	Nutritional Status will be measured by hand grip strength (dynamometer) in kg
Mortality	1 year	Patients who die within 1 year
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)
Occurrence of (Minimal) Hepatic Encephalopathy	1 year	Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)

Secondary Outcome Measures

Name	Time	Method
Change in different metabolites using mass spectroscopy (metabolomics measurements)	12 months	More than 300 metabolites will be measured
Analysis of stool samples	12 months	Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)
Change in inflammatory markers (e.g. cytokine)	12 months	Different cytokines and markers of bacterial translocation (e.g. LPS) are 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
Measurement of portal hypertension	6 months	Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Lower Saxony, Germany