Hypertension, PortalNCT03459378
Outcome After TIPS
An observational study of Hypertension, Portal and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
Trial summary
This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hypertension, Portal, Liver Cirrhosis, Variceal Hemorrhage
- How many people
- 158 participants
- Where
- 1 siteAustria
- Study dates
- 23 Mar 2018to 14 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: Patients at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Who may be able to join
- every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Who cannot join
- age under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.
Read the detailed description
The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. It can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger.
However, this invasive procedure carries a high risk for complications. 30-days mortality after TIPS implantation amounts between 4% and 45%.
A common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after TIPS implantation.
Other complications that are directly related to the intervention are bleeding, infections and stent migration.
Aim of this retrospective single centre study is to investigate the long-term outcome after TIPS implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy.
Intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against TIPS.
- Being tested
- no intervention - retrospective analyses
- Medical subject headings
- Hypertension, Portal, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention - retrospective analysesOther
retrospective data examination, there are no study related interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
transplantation free survival
Survival without liver Transplantation in days
Measured: from date of TIPS until the event, up to 4 years
Secondary outcomes (2)
occurrence of hepatic encephalopathy
time to occurrence of the first episode of hepatic encephalopathy in days
Measured: from date of TIPS until the event, up to 4 years
occurrence of ascites
time to (re)occurrence of ascites in days
Measured: from date of TIPS until the event, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2018
- Study start23 Mar 2018
- Primary completion1 Mar 2019
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension, PortalStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03459378
- Sponsor's protocol ID
- Retro-TIPS
- Status last verified
- May 2020
- First submitted
- 26 Feb 2018
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Furschuss L, Rainer F, Effenberger M, Niederreiter M, Portugaller RH, Horvath A, Fickert P, Stadlbauer V. A novel score predicts mortality after transjugular intrahepatic portosystemic shunt: MOTS - Modified TIPS Score. Liver Int. 2022 Aug;42(8):1849-1860. doi: 10.1111/liv.15236. Epub 2022 Apr 1.
PubMed 35261130
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Outcome After Implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS)
- ClinicalTrials.gov ID
- NCT03459378
- Acronym / sponsor ID
- Retro-TIPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 8 Mar 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.
This clinical trial is a retrospective single-centre study. Research data will be acquired via patient histories stored in the hospital data system. Data of patients who received a Transjugular Intrahepatic Portosystemic Shunt (TIPS) at the University Hospital Graz between 1.1.2004 and 31.12.2017 will be included into the study. The aim is to investigate the outcome (transplantation free survival, time to (re)occurrence of ascites, occurrence of hepatic encephalopathy) of patients with portal hypertension after TIPS.
Detailed description
The implantation of a Transjugular Intrahepatic Portosystemic Shunt (TIPS) is a valuable measure to reduce portal hypertension and prevent portal hypertension-related complications. It can be used as a symptomatic treatment in patients with chronic portal hypertension as well as for the treatment of active variceal bleedings or large gastrointestinal varices that go along with threatening bleeding danger.
However, this invasive procedure carries a high risk for complications. 30-days mortality after TIPS implantation amounts between 4% and 45%.
A common complication is the (initial) manifestation or deterioration of hepatic encephalopathy, which occurs in 33-46 % after TIPS implantation.
Other complications that are directly related to the intervention are bleeding, infections and stent migration.
Aim of this retrospective single centre study is to investigate the long-term outcome after TIPS implantation with regard to transplantation free survival and time to (re-) occurrence of portal hypertension-related complications, especially ascites and hepatic encephalopathy.
Intervention-related complications as well as long-term effects should be evaluated to facilitate the decision for or against TIPS.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Key inclusion criteria (1 listed)
- every person at the age of 18-90 years who received a Transjugular Intrahepatic Portosystemic Shunt at the University Hospital of Graz/Austria between 1.1.2004 and 31.12.2017
Key exclusion criteria (1 listed)
- age under 18
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 |
|---|---|---|
| no intervention - retrospective analysesretrospective data examination, there are no study related interventions | Other | – |
Primary outcome
transplantation free survival
Time frame: from date of TIPS until the event, up to 4 years
Survival without liver Transplantation in days
2 secondary outcomes
occurrence of hepatic encephalopathy
Time frame: from date of TIPS until the event, up to 4 years
occurrence of ascites
Time frame: from date of TIPS until the event, up to 4 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 15 May 2020.
- Derived from this study: PubMed 35261130Furschuss L, Rainer F, Effenberger M, Niederreiter M, Portugaller RH, Horvath A, Fickert P, Stadlbauer V. A novel score predicts mortality after transjugular intrahepatic portosystemic shunt: MOTS - Modified TIPS Score. Liver Int. 2022 Aug;42(8):1849-1860. doi: 10.1111/liv.15236. Epub 2022 Apr 1.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hypertension, Portal and Liver Cirrhosis, run by Medical University of Graz at 1 site in Austria.
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 15 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 Austria. 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?
transplantation free survival (time frame: from date of TIPS until the event, up to 4 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 NCT03459378, which also lists 1 linked publication.
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 15 May 2020.