Portal HypertensionTIPS-SWENCT03072615
Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS
An observational study of Portal Hypertension and Liver Cirrhoses, run by Jonel Trebicka.
Trial summary
The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Hypertension, Liver Cirrhoses
- What is being tested?
- Stiffness measurement
- How many people
- 83 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2013to 29 Feb 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective multicentre study included patients, which underwent TIPS insertion and had reliable SWE or TE measurement of the liver before TIPS.
Who may be able to join
- TIPS insertion and had reliable SWE or TE measurement
Who cannot join
- contraindication for TIPS
- no reliable SWE or TE measurement
About this study
The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).
Read the detailed description
We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.
- Conditions
- Portal Hypertension, Liver Cirrhoses
- Being tested
- Stiffness measurement
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stiffness measurementDiagnostic test
Transient Elastopgraphy (TE) or Shear-Wave-Elastography
| Study group | Role | What they receive |
|---|---|---|
| 1 | receiving TE before and 30 min after TIPS Receives: Diagnostic Test: Stiffness measurement | |
| 2 | receiving SWE before and 7 days, 6 weeks and 3 months after TIPS Receives: Diagnostic Test: Stiffness measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Measured: 3 months
Secondary outcomes (1)
Acute-on-chronic Lvier failure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start1 Apr 2013
- Primary completion30 Nov 2015
- Study completion29 Feb 2016
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 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
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonel Trebicka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonel Trebicka, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072615
- Sponsor's protocol ID
- TIPS-SWE
- Acronym
- TIPS-SWE
- Status last verified
- Mar 2017
- First submitted
- 2 Mar 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20.
PubMed 29059466
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SWE-change After TIPS in the Prediction of Prognosis After TIPS
- ClinicalTrials.gov ID
- NCT03072615
- Acronym / sponsor ID
- TIPS-SWE / TIPS-SWE
- Conditions
- Portal Hypertension, Liver Cirrhoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Jonel TrebickaUniversity, hospital or other
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 7 Mar 2017 (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.
The aim of our prospective multicenter study was to investigate the prognostic value of the acute and long-term changes of liver stiffness in patients receiving a transjugular intrahepatic portosystemic shunt (TIPS).
Detailed description
We included 83 patients receiving TIPS for prevention of rebleeding, therapy-refractory ascites or both. Hemodynamic parameters were assessed before TIPS and after TIPS insertion. 16 patients from Freiburg underwent TE immediately before and after TIPS. In 67 patients from Bonn, SWE of liver and spleen, as well as clinical and biochemical parameters were assessed before TIPS, seven days and six weeks after TIPS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Stiffness measurementreceiving TE before and 30 min after TIPS |
| 2 | – | Diagnostic Test: Stiffness measurementreceiving SWE before and 7 days, 6 weeks and 3 months after TIPS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective multicentre study included patients, which underwent TIPS insertion and had reliable SWE or TE measurement of the liver before TIPS.
Key inclusion criteria (1 listed)
- TIPS insertion and had reliable SWE or TE measurement
Key exclusion criteria (2 listed)
- contraindication for TIPS
- no reliable SWE or TE measurement
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 |
|---|---|---|
| Stiffness measurementTransient Elastopgraphy (TE) or Shear-Wave-Elastography | Diagnostic test | 1, 2 |
Primary outcome
Survival
Time frame: 3 months
1 secondary outcome
Acute-on-chronic Lvier failure
Time frame: 3 months
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 7 Mar 2017.
- Derived from this study: PubMed 29059466Jansen C, Moller P, Meyer C, Kolbe CC, Bogs C, Pohlmann A, Schierwagen R, Praktiknjo M, Abdullah Z, Lehmann J, Thomas D, Strassburg CP, Latz E, Mueller S, Rossle M, Trebicka J. Increase in liver stiffness after transjugular intrahepatic portosystemic shunt is associated with inflammation and predicts mortality. Hepatology. 2018 Apr;67(4):1472-1484. doi: 10.1002/hep.29612. Epub 2018 Feb 20.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Hypertension and Liver Cirrhoses, run by Jonel Trebicka.
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 2 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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: 3 months). 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 NCT03072615, 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 7 Mar 2017.