Minneapolis, Minnesota 55455

  • Portal Hypertension

Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - • 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 - 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 Exclusion Criteria: - 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 - 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)


Study is Available At:


Original ID:

RAD-2016-25151


NCT ID:

NCT03532750


Secondary ID:


Study Acronym:


Brief Title:

Splenic Embolization for Portal Hypertension


Official Title:

Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

22 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Minnesota


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

30


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Shamar Young, MD
Principal Investigator
University of Minnesota
Primary Contact:Shamar Young, MD
612-626-5388
youn1862@umn.edu
Backup Contact:Nichole Kent
612-624-6904
simme033@umn.edu

Study Dates

Start Date:November 1, 2018
Completion Date:July 1, 2021
Completion Type:Anticipated
Primary Completion Date:July 1, 2021
Primary Completion Type:Anticipated
Verification Date:September 2020
Last Changed Date:September 2, 2020
First Received Date:April 25, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Portal Vein Velocity
Time Frame:pre-procedural and at 1, 6 and 12 months
Safety Issues:False
Description:Changes in flow volume and velocity as evidenced by ultra sound
Outcome Type:Secondary Outcome
Measure:Splenic Size
Time Frame:pre-procedural and at 1,3,6 and 12 months
Safety Issues:False
Description:Changes in size of spleen as indicated by MRI or CT
Outcome Type:Secondary Outcome
Measure:Ascites Production
Time Frame:pre-procedural and at 1, 3, and 6 months
Safety Issues:False
Description:Fluid production
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description:Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)
Outcome Type:Primary Outcome
Measure:Change in Quality of Life
Time Frame:pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
Safety Issues:False
Description:Administration of the Chronic Liver Disease Questionnaire (CLDQ)

Study Interventions

Intervention Type:Device
Name:Coil
Description:Ruby or Interlock detachable coils
Arm Name:Coil
Other Name:Ruby Detachable Coils
Intervention Type:Device
Name:Particle
Description: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.
Arm Name:Particle
Other Name:Embosphere Particles

Study Arms

Study Arm Type:Experimental
Arm Name:Coil
Description:Randomized to receive either Ruby or Interlock detachable coils
Study Arm Type:Experimental
Arm Name:Particle
Description:Randomized to receive either the Embozene or Embosphere particles
Study Arm Type:No Intervention
Arm Name:Control
Description:This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Minnesota

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 25, 2021

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