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Splenic Embolization for Portal Hypertension

Primary Purpose

Portal Hypertension

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Particle
Coil
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Portal Hypertension

Eligibility Criteria

22 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Particle

Coil

Arm Description

This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid.

Randomized to receive either the Embozene or Embosphere particles

Randomized to receive either Ruby or Interlock detachable coils

Outcomes

Primary Outcome Measures

Change in Quality of Life
Administration of the Chronic Liver Disease Questionnaire (CLDQ)
Incidence of Treatment Adverse Events
Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)

Secondary Outcome Measures

Ascites Production
Fluid production
Splenic Size
Changes in size of spleen as indicated by MRI or CT
Portal Vein Velocity
Changes in flow volume and velocity as evidenced by ultra sound

Full Information

First Posted
April 25, 2018
Last Updated
March 17, 2022
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03532750
Brief Title
Splenic Embolization for Portal Hypertension
Official Title
Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid.
Arm Title
Particle
Arm Type
Experimental
Arm Description
Randomized to receive either the Embozene or Embosphere particles
Arm Title
Coil
Arm Type
Experimental
Arm Description
Randomized to receive either Ruby or Interlock detachable coils
Intervention Type
Device
Intervention Name(s)
Particle
Other Intervention Name(s)
Embosphere Particles, Embozene Particles
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Coil
Other Intervention Name(s)
Ruby Detachable Coils, Interlock Detachable Coils
Intervention Description
Ruby or Interlock detachable coils
Primary Outcome Measure Information:
Title
Change in Quality of Life
Description
Administration of the Chronic Liver Disease Questionnaire (CLDQ)
Time Frame
pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
Title
Incidence of Treatment Adverse Events
Description
Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)
Time Frame
Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months
Secondary Outcome Measure Information:
Title
Ascites Production
Description
Fluid production
Time Frame
pre-procedural and at 1, 3, and 6 months
Title
Splenic Size
Description
Changes in size of spleen as indicated by MRI or CT
Time Frame
pre-procedural and at 1,3,6 and 12 months
Title
Portal Vein Velocity
Description
Changes in flow volume and velocity as evidenced by ultra sound
Time Frame
pre-procedural and at 1, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamar Young, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

Splenic Embolization for Portal Hypertension

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