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NCT Number: NCT04801290

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).

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Key information

Conditions

Decompensated Liver Cirrhosis Ascites Digestive System Diseases Fibrosis Hypertension, Portal Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

Location status: Recruiting

Location contact

Benjamin Maasoumy, PD

CONTACT

[email protected]

+49 511 532-6529

Benjamin Maasoumy, PD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIPS insertion

Procedure

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

Primary outcomes

  1. Mortality

    Time frame: 1 year

    Patients who die within 1 year

  2. 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)

  3. Change in Nutritional Status

    Time frame: 1 year

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

  4. 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)

Secondary outcomes

  1. Change in inflammatory markers (e.g. cytokine)

    Time frame: 12 months

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

  2. Change in different metabolites using mass spectroscopy (metabolomics measurements)

    Time frame: 12 months

    More than 300 metabolites will be measured

  3. 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

  4. Analysis of stool samples

    Time frame: 12 months

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

  5. Measurement of portal hypertension

    Time frame: 6 months

    Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin Maasoumy, PD

CONTACT

[email protected]

+49 511 532-6529

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Mar 17, 2021
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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