Recruiting NCT04801290
TIPS in Patients With Decompensated Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIPS insertion.
- Who it may be relevant to
- Registry conditions: Decompensated Liver Cirrhosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis
Overview
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).
Interventions
- 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.
Primary outcome measures
- Mortality [Time frame: 1 year]
- Occurrence of (Minimal) Hepatic Encephalopathy [Time frame: 1 year]
- Change in Nutritional Status [Time frame: 1 year]
- Change in Quality of Life [Time frame: 1 year]
Secondary outcome measures (5)
- Change in inflammatory markers (e.g. cytokine) [Time frame: 12 months]
- Change in different metabolites using mass spectroscopy (metabolomics measurements) [Time frame: 12 months]
- Analysis of cellular immunity by collection of peripheral blood mononuclear cells (PBMCs) [Time frame: 12 months]
- Analysis of stool samples [Time frame: 12 months]
- Measurement of portal hypertension [Time frame: 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Hannover Medical School — Hanover
Publications
- Dinkelborg K, Niehaus C, Bremer B, Wundes C, Tiede A, Petruch N, Deterding K, Kraft ARM, Hartleben B, Cornberg M, Wedemeyer H, Behrendt P, Maasoumy B. Acute HEV Infection Is a Relevant Cause of Decompensation and ACLF in Patients With Liver Cirrhosis. Liver Int. 2026 Jul;46(7):e70727. doi: 10.1111/liv.70727. PMID 42261201
- Sandmann L, Egge JFM, Tiede A, Ehrenbauer AF, Kabelitz MA, Rieland H, Mauz JB, Meyer BC, Wedemeyer H, Weissenborn K, Maasoumy B. Plasma Ammonia Levels Predict Hepatic Encephalopathy After Transjugular Intrahepatic Portosystemic Shunt Placement. United European Gastroenterol J. 2025 Sep;13(7):1171-1183. doi: 10.1002/ueg2.70095. Epub 2025 Aug 9. PMID 40782353
- Kabelitz MA, Gairing SJ, Tiede A, Schleicher EM, Ahl LG, Wagner L, Zucker-Reimann F, Rieland H, Mauz JB, Weinmann-Menke J, Meyer BC, Pitton MB, Wedemeyer H, Galle PR, Sandmann L, Maasoumy B, Labenz C. Impact of Frailty on the Prognosis of Patients With Liver Cirrhosis Undergoing Insertion of a TIPS. Aliment Pharmacol Ther. 2026 Jan;63(1):109-118. doi: 10.1111/apt.70315. Epub 2025 Aug 1. PMID 40751304
- Ehrenbauer AF, Schneider H, Stockhoff L, Tiede A, Lorenz C, Dirks M, Witt J, Gabriel MM, Wedemeyer H, Hinrichs JB, Weissenborn K, Maasoumy B. Predicting overt hepatic encephalopathy after TIPS: Value of three minimal hepatic encephalopathy tests. JHEP Rep. 2023 Jun 28;5(9):100829. doi: 10.1016/j.jhepr.2023.100829. eCollection 2023 Sep. PMID 37600959
Identifiers
NCT: NCT04801290 · BM_84982019