Splenic Embolization for Portal Hypertension

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.

Study Overview

• Status: Withdrawn
• Conditions: Portal Hypertension
• Intervention / Treatment: Device: Particle; Device: Coil

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid.
Experimental: Particle; Randomized to receive either the Embozene or Embosphere particles	Device: Particle; 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.; Other Names: Embosphere Particles; Embozene Particles
Experimental: Coil; Randomized to receive either Ruby or Interlock detachable coils	Device: Coil; Ruby or Interlock detachable coils; Other Names: Ruby Detachable Coils; Interlock Detachable Coils

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Administration of the Chronic Liver Disease Questionnaire (CLDQ)	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)	Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ascites Production	Fluid production	pre-procedural and at 1, 3, and 6 months
Splenic Size	Changes in size of spleen as indicated by MRI or CT	pre-procedural and at 1,3,6 and 12 months
Portal Vein Velocity	Changes in flow volume and velocity as evidenced by ultra sound	pre-procedural and at 1, 6 and 12 months

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Shamar Young, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: April 25, 2018
• First Submitted That Met QC Criteria: May 9, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 17, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Hypertension; Hypertension, Portal
• Other Study ID Numbers: RAD-2016-25151

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes