Portal HypertensionNEPTUNNCT03628807
Non-invasive Evaluation Program for TIPS and Follow Up Network
An observational study of Portal Hypertension, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Portal Hypertension
- How many people
- 747 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 1999to 11 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients receiving TIPS according to guidelines
Who may be able to join
- Insertion of TIPS according to guidelines
Who cannot join
- Contraindication for TIPS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Read the detailed description
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
- Conditions
- Portal Hypertension
- Keywords
- transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), circulating biomarkers, Electroencephalography (EEG)
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective 1 | Retrospective Bare Metal Stent Cohort that received TIPS from 01/01/1996 to 12/31/2003. | |
| Retrospective 2 | Retrospective Covered Stent Cohort that received TIPS from 01/01/2004 to 12/31/2012. | |
| Prospective | Prospective cohort that received TIPS from 01/01/2013 onwards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
death, liver transplantation
Measured: up to 10 years
Secondary outcomes (6)
Ascites
Evaluation of amount of ascites according to the Child-Score
Measured: up to 10 years
Hepatic Encephalopathy
Evaluation of the grade according to the West Haven Criteria
Measured: up to 10 years
Variceal Bleeding
Assessment of presence of variceal bleeding
Measured: up to 10 years
Liver Failure
defined as Bilirubin level ≥ 12mg/dl
Measured: up to 10 years
Acute-on-Chronic-Liver Failure (ACLF)
Presence of ACLF according to the EASL-Chronic liver Failure Consortium (CLIF)-criteria
Measured: up to 10 years
Organ Failures
Assessment of Organ failures according to the CLIF-SOFA
according to CLIF-Sequential Organ Failure Assessment (SOFA) Score
Measured: up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jan 1999
- Primary completion11 May 2020
- Study completion11 May 2020
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 Portal HypertensionStudies 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
- Other
- Enrolment
- 747 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonel Trebicka, University Hospital, Bonn
- Investigators
- Michael Praktiknjo, MD, Principal investigator, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628807
- Sponsor's protocol ID
- NEPTUN
- Acronym
- NEPTUN
- Status last verified
- May 2020
- First submitted
- 11 Jul 2018
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meyer C, Kimmann M, Bohm K, Nowak S, Perez AMP, Meier JA, Reinartz Groba SN, Godiker J, Uschner FE, Sanoubara F, Chang J, Trebicka J, Sprinkart AM, Praktiknjo M. Three-Dimensional Transjugular Intrahepatic Portosystemic Shunt Geometry Predicts Shunt Dysfunction. Aliment Pharmacol Ther. 2025 Jun;61(11):1805-1814. doi: 10.1111/apt.70133. Epub 2025 Apr 9.
PubMed 40202365Queck A, Schwierz L, Gu W, Ferstl PG, Jansen C, Uschner FE, Praktiknjo M, Chang J, Brol MJ, Schepis F, Merli M, Strassburg CP, Lehmann J, Meyer C, Trebicka J. Targeted decrease of portal hepatic pressure gradient improves ascites control after TIPS. Hepatology. 2023 Feb 1;77(2):466-475. doi: 10.1002/hep.32676. Epub 2022 Aug 12.
PubMed 35869810Praktiknjo M, Abu-Omar J, Chang J, Thomas D, Jansen C, Kupczyk P, Schepis F, Garcia-Pagan JC, Merli M, Meyer C, Strassburg CP, Pieper CC, Trebicka J. Controlled underdilation using novel VIATORR(R) controlled expansion stents improves survival after transjugular intrahepatic portosystemic shunt implantation. JHEP Rep. 2021 Mar 3;3(3):100264. doi: 10.1016/j.jhepr.2021.100264. eCollection 2021 Jun.
PubMed 34013182Torner M, Mangal A, Scharnagl H, Jansen C, Praktiknjo M, Queck A, Gu W, Schierwagen R, Lehmann J, Uschner FE, Graf C, Strassburg CP, Fernandez J, Stojakovic T, Woitas R, Trebicka J. Sex specificity of kidney markers to assess prognosis in cirrhotic patients with TIPS. Liver Int. 2020 Jan;40(1):186-193. doi: 10.1111/liv.14230. Epub 2019 Sep 10.
PubMed 31448496Lehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7.
PubMed 30739387
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Evaluation of Prognostic Parameters for Patients With Transjugular Intrahepatic Portosystemic Shunt (TIPS) Using a Structured Follow up Protocol
- ClinicalTrials.gov ID
- NCT03628807
- Acronym / sponsor ID
- NEPTUN / NEPTUN
- Conditions
- Portal Hypertension
- Keywords
- transjugular intrahepatic portosystemic shunt (TIPS), non-invasive assessments, Transthoracic echocardiography (TTE) with Speckle-tracking, Computer tomography scan (CT-scan), Magnetic resonance imaging (MRI), circulating biomarkers, Electroencephalography (EEG)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 747 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 14 Aug 2018 (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.
Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.
Detailed description
NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrospective 1 | – | –Retrospective Bare Metal Stent Cohort that received TIPS from 01/01/1996 to 12/31/2003. |
| Retrospective 2 | – | –Retrospective Covered Stent Cohort that received TIPS from 01/01/2004 to 12/31/2012. |
| Prospective | – | –Prospective cohort that received TIPS from 01/01/2013 onwards |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients receiving TIPS according to guidelines
Key inclusion criteria (1 listed)
- Insertion of TIPS according to guidelines
Key exclusion criteria (1 listed)
- Contraindication for TIPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival
Time frame: up to 10 years
death, liver transplantation
6 secondary outcomes
Ascites
Time frame: up to 10 years
Hepatic Encephalopathy
Time frame: up to 10 years
Variceal Bleeding
Time frame: up to 10 years
Liver Failure
Time frame: up to 10 years
Acute-on-Chronic-Liver Failure (ACLF)
Time frame: up to 10 years
Organ Failures
Time frame: up to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Derived from this study: PubMed 40202365Meyer C, Kimmann M, Bohm K, Nowak S, Perez AMP, Meier JA, Reinartz Groba SN, Godiker J, Uschner FE, Sanoubara F, Chang J, Trebicka J, Sprinkart AM, Praktiknjo M. Three-Dimensional Transjugular Intrahepatic Portosystemic Shunt Geometry Predicts Shunt Dysfunction. Aliment Pharmacol Ther. 2025 Jun;61(11):1805-1814. doi: 10.1111/apt.70133. Epub 2025 Apr 9.
- Derived from this study: PubMed 35869810Queck A, Schwierz L, Gu W, Ferstl PG, Jansen C, Uschner FE, Praktiknjo M, Chang J, Brol MJ, Schepis F, Merli M, Strassburg CP, Lehmann J, Meyer C, Trebicka J. Targeted decrease of portal hepatic pressure gradient improves ascites control after TIPS. Hepatology. 2023 Feb 1;77(2):466-475. doi: 10.1002/hep.32676. Epub 2022 Aug 12.
- Derived from this study: PubMed 34013182Praktiknjo M, Abu-Omar J, Chang J, Thomas D, Jansen C, Kupczyk P, Schepis F, Garcia-Pagan JC, Merli M, Meyer C, Strassburg CP, Pieper CC, Trebicka J. Controlled underdilation using novel VIATORR(R) controlled expansion stents improves survival after transjugular intrahepatic portosystemic shunt implantation. JHEP Rep. 2021 Mar 3;3(3):100264. doi: 10.1016/j.jhepr.2021.100264. eCollection 2021 Jun.
- Derived from this study: PubMed 31448496Torner M, Mangal A, Scharnagl H, Jansen C, Praktiknjo M, Queck A, Gu W, Schierwagen R, Lehmann J, Uschner FE, Graf C, Strassburg CP, Fernandez J, Stojakovic T, Woitas R, Trebicka J. Sex specificity of kidney markers to assess prognosis in cirrhotic patients with TIPS. Liver Int. 2020 Jan;40(1):186-193. doi: 10.1111/liv.14230. Epub 2019 Sep 10.
- Derived from this study: PubMed 30739387Lehmann J, Praktiknjo M, Nielsen MJ, Schierwagen R, Meyer C, Thomas D, Violi F, Strassburg CP, Bendtsen F, Moller S, Krag A, Karsdal MA, Leeming DJ, Trebicka J. Collagen type IV remodelling gender-specifically predicts mortality in decompensated cirrhosis. Liver Int. 2019 May;39(5):885-893. doi: 10.1111/liv.14070. Epub 2019 Mar 7.
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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. This study is not recruiting at the moment.
Michael Praktiknjo, MD principal investigator
University of Bonn
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 Portal Hypertension, run by University Hospital, Bonn 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 May 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: up to 10 years). 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 NCT03628807, 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 12 May 2020.