Clinical trial NCT03532750: Splenic Embolization for Portal Hypertension
Official title: Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Portal Hypertension
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2018-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 randomization of participants in sequential order to either the control group (best medical management), particle embolization, and coil embolization.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Quality of Life
timeFrame: pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
measure: Incidence of Treatment Adverse Events
timeFrame: Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months
Secondary outcomes:
measure: Ascites Production
timeFrame: pre-procedural and at 1, 3, and 6 months
measure: Splenic Size
timeFrame: pre-procedural and at 1,3,6 and 12 months
measure: Portal Vein Velocity
timeFrame: pre-procedural and at 1, 6 and 12 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Shamar Young, MD
role: PRINCIPAL_INVESTIGATOR
References: