TIPS in Patients With Decompensated Liver Cirrhosis

Decompensated Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04801290
• Other study ID #: BM_84982019
• Status: Recruiting
• Start date: August 29, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: Hannover Medical School
• Contact: Benjamin Maasoumy, PD
• Phone: +49 511 532-6529
• Email: Maasoumy.Benjamin[@]mha-hannover.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Decompensated Liver Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

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.

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Patients who die within 1 year	1 year
Primary	Occurrence of (Minimal) Hepatic Encephalopathy	Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)	1 year
Primary	Change in Nutritional Status	Nutritional Status will be measured by hand grip strength (dynamometer) in kg	1 year
Primary	Change in Quality of Life	Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)	1 year
Secondary	Change in inflammatory markers (e.g. cytokine)	Different cytokines and markers of bacterial translocation (e.g. LPS) are measured	12 months
Secondary	Change in different metabolites using mass spectroscopy (metabolomics measurements)	More than 300 metabolites will be measured	12 months
Secondary	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	12 months
Secondary	Analysis of stool samples	Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)	12 months
Secondary	Measurement of portal hypertension	Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion	6 months