Splenic Embolization for Portal Hypertension

NCT03532750 | Withdrawn DMC FDA Device

• 1 other identifier: RAD-2016-25151
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Ascites Production

  pre-procedural and at 1, 3, and 6 months

• Splenic Size

  pre-procedural and at 1,3,6 and 12 months

• Portal Vein Velocity

  pre-procedural and at 1, 6 and 12 months

Study Arms (3)

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

Device: Particle

Coil

EXPERIMENTAL

Randomized to receive either Ruby or Interlock detachable coils

Device: Coil

Interventions

Particle DEVICE

1. 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.

Also known as: Embosphere Particles, Embozene Particles

Particle

Coil DEVICE

Ruby or Interlock detachable coils

Also known as: Ruby Detachable Coils, Interlock Detachable Coils

Coil

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hypertension, Portal

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Shamar Young, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1:1 randomization of participants in sequential order to either the control group (best medical management), particle embolization, and coil embolization.

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: May 22, 2018
• Study Start: November 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)