Decompensated Liver CirrhosisNCT04801290
TIPS in Patients With Decompensated Liver Cirrhosis
An observational study of Decompensated Liver Cirrhosis, run by Hannover Medical School at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Decompensated Liver Cirrhosis
- What is being tested?
- TIPS insertion
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 29 Aug 2019to Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.
Who may be able to join
- Liver cirrhosis
- Indication for TIPS insertion
- Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
- Informed consent
Who cannot join
- Pregnancy or Lactation
- Age <18 years
- Lack of Informed consent
- Symptomatic anemia with Hb <7g/dl
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Benjamin Maasoumy, PD, +49 511 532-6529, Maasoumy.Benjamin@mh-hannover.de
Benjamin Maasoumy, PD
About this study
Official title: Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (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).
- Conditions
- Decompensated Liver Cirrhosis
- Being tested
- TIPS insertion
- Keywords
- Portal hypertension, TIPS, Refractory ascites, Variceal bleeding, Liver cirrhosis
- Medical subject headings
- Hypertension, Portal, Ascites, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIPS insertionProcedure or surgery
Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.
| Study group | Role | What they receive |
|---|---|---|
| TIPS insertion | Not described Receives: Procedure: TIPS insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Patients who die within 1 year
Measured: 1 year
Occurrence of (Minimal) Hepatic Encephalopathy
Using the Portosystemic encephalopathy (PSE) syndrome test, critical flicker frequency (CFF) and animal naming test (S-ANT)
Measured: 1 year
Change in Nutritional Status
Nutritional Status will be measured by hand grip strength (dynamometer) in kg
Measured: 1 year
Change in Quality of Life
Using the questionnaire short-form 36 (SF36) (Score range 0-100, higher scores correspond to better quality of life)
Measured: 1 year
Secondary outcomes (5)
Change in inflammatory markers (e.g. cytokine)
Different cytokines and markers of bacterial translocation (e.g. LPS) are measured
Measured: 12 months
Change in different metabolites using mass spectroscopy (metabolomics measurements)
More than 300 metabolites will be measured
Measured: 12 months
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
Measured: 12 months
Analysis of stool samples
Analysis of the intestinal microbiome and metagenome analysis (shotgun sequencing)
Measured: 12 months
Measurement of portal hypertension
Measurement of the hepatic venous pressure gradient (HVPG) to ensure the efficacy of the TIPS insertion
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start29 Aug 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Decompensated Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Maasoumy, PD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801290
- Sponsor's protocol ID
- BM_84982019
- Status last verified
- Sep 2025
- First submitted
- 26 Feb 2021
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 42261201Rieland H, Meine TC, Tiede A, Mauz JB, Wedemeyer H, Hinrichs JB, Wacker FK, Maasoumy B. Expandable Constrained Transjugular Intrahepatic Portosystemic Shunt: An Individualised Approach for High-Risk Patients? Liver Int. 2026 Jan;46(1):e70436. doi: 10.1111/liv.70436.
PubMed 41420273Sandmann 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.
PubMed 40782353Kabelitz 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.
PubMed 40751304Ehrenbauer 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.
PubMed 37600959
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits and Limitations of Transjugular Intrahepatic Portosystemic Shunts (TIPS) in Patients With Decompensated Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04801290
- Acronym / sponsor ID
- BM_84982019
- Conditions
- Decompensated Liver Cirrhosis
- Keywords
- Portal hypertension, TIPS, Refractory ascites, Variceal bleeding, Liver cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIPS insertion | – | Procedure: TIPS insertion |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with decompensated liver cirrhosis and an indication for TIPS placement at Hannover Medical School.
Key inclusion criteria (4 listed)
- Liver cirrhosis
- Indication for TIPS insertion
- Treatment at the Department of Gastroenterology, Hepatology and Endocrinology of Hannover Medical School
- Informed consent
Key exclusion criteria (4 listed)
- Pregnancy or Lactation
- Age <18 years
- Lack of Informed consent
- Symptomatic anemia with Hb <7g/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TIPS insertionPatients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent. | Procedure or surgery | TIPS insertion |
Primary outcome
Mortality
Time frame: 1 year
Patients who die within 1 year
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)
Change in Nutritional Status
Time frame: 1 year
Nutritional Status will be measured by hand grip strength (dynamometer) in kg
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)
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Derived from this study: PubMed 42261201Dinkelborg 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.
- Derived from this study: PubMed 41420273Rieland H, Meine TC, Tiede A, Mauz JB, Wedemeyer H, Hinrichs JB, Wacker FK, Maasoumy B. Expandable Constrained Transjugular Intrahepatic Portosystemic Shunt: An Individualised Approach for High-Risk Patients? Liver Int. 2026 Jan;46(1):e70436. doi: 10.1111/liv.70436.
- Derived from this study: PubMed 40782353Sandmann 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.
- Derived from this study: PubMed 40751304Kabelitz 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.
- Derived from this study: PubMed 37600959Ehrenbauer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Benjamin Maasoumy, PD principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Decompensated Liver Cirrhosis, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Maasoumy, PD (+49 511 532-6529, Maasoumy.Benjamin@mha-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04801290, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.