Portal HypertensionNCT03352882
Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
A study testing Ultrasound in people with Portal Hypertension and Liver Fibroses, run by University of Pennsylvania at 1 site in United States.
Trial summary
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Portal Hypertension, Liver Fibroses
- What is being tested?
- Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 3 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
- Age >18, Age <80
- Capable of giving informed consent
Who cannot join
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- BMI >35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate elastography measurements in patients with fatty liver)
- Urgent or emergent TIPS for bleeding
- Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein
- Hepatic vein thrombosis (ie no Budd Chiari syndrome)
Show all 10Show fewer
- Excessive alcohol use defined as more than 2 oz in 24 hours on any individual day within the last 30 days
- Inability to provide informed consent
- Pregnant or nursing women
- Enrollment in concurrent therapeutic trial for symptomatic portal hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
Read the detailed description
Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.
- Conditions
- Portal Hypertension, Liver Fibroses
- Being tested
- Ultrasound
- 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.
UltrasoundDiagnostic test
Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Other | All enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Liver Stiffness
The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by > 50%. Change in liver stiffness will be correlated to change in PSG.
Measured: Pre-TIPS and 30 days Post-TIPS creation
Secondary outcomes (4)
PSG (mm hg) and ARFI (m/s) Correlation
Baseline PSG (mm Hg) correlation to baseline liver stiffness by ultrasound ARFI (m/s)
Measured: Pre-TIPS and 30 days Post-TIPS creation
Frequency of Paracentesis and Recurrence of Variceal Bleeding
Difference in frequency of paracentesis and freedom from recurrence of variceal bleeding at 30 days and 12 months post-TIPS placement
Measured: 30 days Post-TIPS and 12 months Post-TIPS creation
Hyaluronic Acid and ARFI Correlation
Correlation of hyaluronic acid, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness
Measured: Pre-TIPS and 30 days Post-TIPS creation
Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation
Correlation of tissue inhibitor of metalloproteinase-1, a serum marker of liver stiffness, with baseline ARFI measurements, non-invasive radiographic assessment of liver stiffness
Measured: Pre-TIPS and 30 days Post-TIPS creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startAug 2016
- Primary completion3 Apr 2019
- Study completion3 Apr 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kimberly Forde, MD, MHS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352882
- Sponsor's protocol ID
- 826196
- Other IDs
- U54CA193417
- Status last verified
- Sep 2019
- First submitted
- 4 Oct 2017
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transjugular Intrahepatic Portosystemic Shunts on Liver Stiffness
- ClinicalTrials.gov ID
- NCT03352882
- Acronym / sponsor ID
- 826196
- Conditions
- Portal Hypertension, Liver Fibroses
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2016 (actual)
- Primary completion
- 3 Apr 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study examining changes in liver stiffness measured by ultrasound before and after TIPS creation
Detailed description
Single arm pilot study of adults ≥18yo investigating changes in liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Duration of participation is 30 days from TIPS creation. TIPS creation with Viatorr stent graft will be in accordance with its FDA-approved indication for symptomatic portal hypertension and per the manufacturer's instructions for use. Liver stiffness will be measured on pre-TIPS and post-TIPS ultrasounds using Phillips Epiq Ultrasound systems equipped with ElastPQ ultrasound shear wave elastography. Both ultrasounds will be performed at times which are standard of care before and after TIPS creation. Primary objectives include liver stiffness as measured by ultrasound acoustic radiation force impulse (ARFI) before and after creation of TIPS. Secondary objectives include change in portosystemic gradient, clinical success as measured by difference in frequency of repeat paracentesis post-TIPS or freedom from recurrence of variceal bleeding and rate of hepatic encephalopathy. Exploratory objectives include serum biomarkers of liver stiffness.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | Other | Diagnostic Test: UltrasoundAll enrolled participants will undergo hepatic ultrasound with acoustic radiation force impulse (ARFI) before and 30 days after creation of TIPS. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic portal hypertension secondary to cirrhosis undergoing elective outpatient TIPS
- Age >18, Age <80
- Capable of giving informed consent
Key exclusion criteria (10 listed)
- Coagulopathy defined as international normalized ration (INR) >2 which cannot be corrected with fresh frozen plasma
- Platelet count <50,000/microliter, which cannot be corrected with platelet transfusion
- BMI >35 and/or cirrhosis due to non-alcoholic steatohepatitis (due to inaccurate elastography measurements in patients with fatty liver)
- Urgent or emergent TIPS for bleeding
- Portal vein thrombosis with in the main, 1st, or 2nd order branches of the portal vein
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 |
|---|---|---|
| UltrasoundHepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded. | Diagnostic test | Open Label |
Primary outcome
Decrease in Liver Stiffness
Time frame: Pre-TIPS and 30 days Post-TIPS creation
The primary study endpoint will be decrease in liver stiffness following TIPS creation as measured by ARFI using mean propagation velocity values in meters per second. Mean normal values and mean values indicating severe fibrosis range about 0.8-1.7 m/s and about 1-3.4 m/s respectively. We hypothesize TIPS creation will reduce the liver stiffness by > 50%. Change in liver stiffness will be correlated to change in PSG.
4 secondary outcomes
PSG (mm hg) and ARFI (m/s) Correlation
Time frame: Pre-TIPS and 30 days Post-TIPS creation
Frequency of Paracentesis and Recurrence of Variceal Bleeding
Time frame: 30 days Post-TIPS and 12 months Post-TIPS creation
Hyaluronic Acid and ARFI Correlation
Time frame: Pre-TIPS and 30 days Post-TIPS creation
Tissue Inhibitor of Metalloproteinase-1 and ARFI Correlation
Time frame: Pre-TIPS and 30 days Post-TIPS creation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kimberly Forde, MD, MHS principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound in people with Portal Hypertension and Liver Fibroses, run by University of Pennsylvania at 1 site in United States.
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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 1 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Decrease in Liver Stiffness (time frame: Pre-TIPS and 30 days Post-TIPS creation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2019.