Portal HypertensionNCT03532750
Splenic Embolization for Portal Hypertension
A study testing Particle and Coil in people with Portal Hypertension, run by University of Minnesota at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety and efficacy of partial splenic artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim is to evaluate the relative efficacy of two separate splenic artery embolization techniques, coiling versus particle embolization of… Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Portal Hypertension
- What is being tested?
- Particle and Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2018to 1 Jul 2021
- Phase
- Interventional
- 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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patients who are between 22-70 years of age.
- Patient must have portal hypertension; as defined by: refractory ascites or unilateral right sided pleural effusions with concomitant liver cirrhosis and splenomegaly (spleen > 11 cm on CT or US).
- Medically refractive/intolerant, ascites or unilateral right sided pleural effusions consistent with hepatic hydrothorax. Medically refractive defined as those with persistent need for paracentesis or thoracentesis despite maximal doses of diuretics (400 mg spironolactone and 160 mg furosemide per day) or those who are intolerant of furosemide (develop azotemia, electrolyte imbalance, encephalopathy or renal failure) or spironolactone (develop gynecomastia, decreased libido, and hyperkalemia).
- Patients will need to meet one or more of the following requirements:
- MELD >18 but <35
- Anatomic variation making TIPS impossible/difficult
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- Previous failed attempt to place TIPS
- Unwilling to undergo TIPS
- History of severe hepatic encephalopathy
- Thrombosis of the hepatic veins
- Willing and able to provide informed consent
Who cannot join
- Patients < 22 and >70 years of age
- Patients with CLDQ score of >6 or <2
- Patients with a weight >400 pounds
- Patients with primary or secondary splenic cancer
- Currently pregnant
- Current systemic infection
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- Patients who have undergone prior splenectomy or other splenic surgery
- Patients who have previously undergone splenic artery embolization for any reason (likely reasons would be trauma or thrombocytopenia)
- Patients with splenic vascular anatomy that would increase the risk of non-target embolization.
- Patients who have a INR or platelet count which are not correctable to <1.8 and >35,000 respectively
- Anaphylaxis to intravenous contrast.
- Patients diagnosed with Budd-Chiari Syndrome (This will be assessed on pre-intervention CTA)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
The primary purpose of this study is to evaluate the safety and efficacy of partial splenic artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim is to evaluate the relative efficacy of two separate splenic artery embolization techniques, coiling versus particle embolization of the spleen. These two methods will be compared to standard medical management which consist of pain management and fluid draining.
Read the detailed description
This is a single center phase I/II study that is designed to assess the safety and efficacy of splenic artery embolization in the setting of symptomatic portal hypertension. All participating investigators have signed the protocol agreement and no investigator will be added until they sign the agreement. The study will not be initiated until FDA and IRB approval is obtained.
The study will consist of a 4 week screening period, day of treatment, and 12-month follow-up period. 60 subjects will be enrolled, with a goal of randomizing 30, at the University of Minnesota Medical Center. Enrollment is expected to take up to 48 months. The collection of data will be accomplished by utilizing a clinical research team that will obtain symptomatic portal hypertension improvement and safety assessments. Efficacy assessments will include; change in portal vein velocity, ascitic fluid production change, reduction in splenic size, and improvement in quality of life (QoL). Safety assessments include subject and investigator reported adverse events, subjective pain, and splenic abscess formation.
- Conditions
- Portal Hypertension
- Being tested
- Particle, Coil
- Medical subject headings
- Hypertension, Portal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParticleDevice
Also called Embosphere Particles, Embozene Particles
- 300-500 µm Embosphere Particles, Merit Medical (Rockland, MA) 501(k) number K991549.
- 300-500 µm Embozene Particles, Boston Scientific (Marlborough, MA) 501(k) number K133447.
- Ruby detachable coils, Penumbra (Alameda, CA) 501(K) number K103305.
- Interlock detachable coils, Boston Scientific (Marlborough, MA) 501(k) number K132578.
CoilDevice
Also called Ruby Detachable Coils, Interlock Detachable Coils
Ruby or Interlock detachable coils
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid. |
| Particle | Experimental | Randomized to receive either the Embozene or Embosphere particles Receives: Device: Particle |
| Coil | Experimental | Randomized to receive either Ruby or Interlock detachable coils Receives: Device: Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life
Administration of the Chronic Liver Disease Questionnaire (CLDQ)
Measured: pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
Incidence of Treatment Adverse Events
Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)
Measured: Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months
Secondary outcomes (3)
Ascites Production
Fluid production
Measured: pre-procedural and at 1, 3, and 6 months
Splenic Size
Changes in size of spleen as indicated by MRI or CT
Measured: pre-procedural and at 1,3,6 and 12 months
Portal Vein Velocity
Changes in flow volume and velocity as evidenced by ultra sound
Measured: pre-procedural and at 1, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start1 Nov 2018
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1:1 randomization of participants in sequential order to either the control group (best medical management), particle embolization, and coil embolization.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shamar Young, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532750
- Sponsor's protocol ID
- RAD-2016-25151
- Status last verified
- Mar 2022
- First submitted
- 25 Apr 2018
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All IPD generated for this study will only be reviewed by the study personnel who have been approved by the IRB. Any results that are shared, will be aggregate group data that does not address any individual participant directly.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
- ClinicalTrials.gov ID
- NCT03532750
- Acronym / sponsor ID
- RAD-2016-25151
- Conditions
- Portal Hypertension
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 22 May 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.
The primary purpose of this study is to evaluate the safety and efficacy of partial splenic artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim is to evaluate the relative efficacy of two separate splenic artery embolization techniques, coiling versus particle embolization of the spleen. These two methods will be compared to standard medical management which consist of pain management and fluid draining.
Detailed description
This is a single center phase I/II study that is designed to assess the safety and efficacy of splenic artery embolization in the setting of symptomatic portal hypertension. All participating investigators have signed the protocol agreement and no investigator will be added until they sign the agreement. The study will not be initiated until FDA and IRB approval is obtained.
The study will consist of a 4 week screening period, day of treatment, and 12-month follow-up period. 60 subjects will be enrolled, with a goal of randomizing 30, at the University of Minnesota Medical Center. Enrollment is expected to take up to 48 months. The collection of data will be accomplished by utilizing a clinical research team that will obtain symptomatic portal hypertension improvement and safety assessments. Efficacy assessments will include; change in portal vein velocity, ascitic fluid production change, reduction in splenic size, and improvement in quality of life (QoL). Safety assessments include subject and investigator reported adverse events, subjective pain, and splenic abscess formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 1:1:1 randomization of participants in sequential order to either the control group (best medical management), particle embolization, and coil embolization.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid. |
| Particle | Experimental | Device: ParticleRandomized to receive either the Embozene or Embosphere particles |
| Coil | Experimental | Device: CoilRandomized to receive either Ruby or Interlock detachable coils |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Patients who are between 22-70 years of age.
Key exclusion criteria (12 listed)
- Patients < 22 and >70 years of age
- Patients with CLDQ score of >6 or <2
- Patients with a weight >400 pounds
- Patients with primary or secondary splenic cancer
- Currently pregnant
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 |
|---|---|---|
| ParticleAlso: Embosphere Particles, Embozene Particles1. 300-500 µm Embosphere Particles, Merit Medical (Rockland, MA) 501(k) number K991549. 2. 300-500 µm Embozene Particles, Boston Scientific (Marlborough, MA) 501(k) number K133447. 3. Ruby detachable coils, Penumbra (Alameda, CA) 501(K) number K103305. 4. Interlock detachable coils, Boston Scientific (Marlborough, MA) 501(k) number K132578. | Device | Particle |
| CoilAlso: Ruby Detachable Coils, Interlock Detachable CoilsRuby or Interlock detachable coils | Device | Coil |
Primary outcome
Change in Quality of Life
Time frame: pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
Administration of the Chronic Liver Disease Questionnaire (CLDQ)
Incidence of Treatment Adverse Events
Time frame: Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months
Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)
3 secondary outcomes
Ascites Production
Time frame: pre-procedural and at 1, 3, and 6 months
Splenic Size
Time frame: pre-procedural and at 1,3,6 and 12 months
Portal Vein Velocity
Time frame: pre-procedural and at 1, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: No. All IPD generated for this study will only be reviewed by the study personnel who have been approved by the IRB. Any results that are shared, will be aggregate group data that does not address any individual participant directly.
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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.
Shamar Young, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Particle and Coil in people with Portal Hypertension, run by University of Minnesota 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 11 inclusion and 12 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: withdrawn, as of the sponsor's last update on 31 Mar 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Quality of Life (time frame: pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits). The study lists 2 primary outcomes in all. 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 31 Mar 2022.