Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

Study Overview
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Brief Summary
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The present study aimes at comparing the transradial and transfemoral approaches for partial splenic embolization in patients with hypersplenism.

Detailed Description
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Since its development in 1979, partial splenic embolization (PSE) has been universally accepted to treat patients with hypersplenism in preference to surgical splenectomy. The spleen is the primary source of antibodies, lymphocyte production, and responsible for phagocytosis of white cells. Additionally, it plays an essential role in the immune system. Unlike splenectomy, partial splenic embolization (PSE) maintained partial splenic function and was thought to be an effective alternative to treat thrombocytopenia and leukopenia resulted from hypersplenism with fewer complications. PSE is usually performed using a femoral artery approach that requires bed rest for a few hours. Recently, the transradial approach, with less obvious need for bed rest, has been more widely applied for cardiovascular intervention.

Official Title
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Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial

Conditions
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Hypersplenism

Intervention / Treatment
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* Procedure: partial splenic artery embolization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3). the functional status of the liver should be Child A or early B according to Child-Pugh classification (5-7 points) (albumin ≥ 2.8 g/dL, bilirubin ≤ 3 mg/dL, prothrombin time ≤ 4 or INR < 1.7, no ascites, no encephalopathy). Eligible for both femoral and radial puncture. Exclusion Criteria: Patients referred for embolization as treatment of traumatic splenic injury. Patients lost during follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: femoral puncture<br>Under local anaesthesia, the femoral artery was punctured and 6F sheath was inserted. Splenic artery was catheterized using 4- or 5-F catheters (Cobra C2 cat or Simmons II catheter Imager-Boston Scientific Natick, Massachusetts). Embolization was done using Embospheres (Biosphere Medical, Rockland, MA) 700-900 μ in diameter. | Procedure: partial splenic artery embolization<br>* embolization of the splenic artery for the treatment of hypersplenism<br>|
| Active Comparator: Radial puncture<br>The left radial artery was preferred due to shorter distance from the left wrist to the splenic artery in comparison to the right wrist; also the left radial access theoretically decreases the risk of cerebral emboli. Under local anaesthesia and ultrasound guidance, the radial artery was punctured and 5- or 6-F sheath was introduced. After sheath insertion, the radial cocktail (2.5 mg of verapamil, 100 μg of nitroglycerin, and 5,000 units of heparin) was injected through the sheath over one minute after dilution with 20 ml of blood to decrease the discomfort during injection. | Procedure: partial splenic artery embolization<br>* embolization of the splenic artery for the treatment of hypersplenism<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success of the Procedure | The achievement of a single puncture allowing access to splenic artery without periprocedural complications. | Immediately after the procedure is complete | 
| Average number of punctures | Number of arterial punctures required to complete the procedure | Immediately after the procedure is complete | 
| Procedural time | The time interval from starting the anaethesia till completion of the procedure | Immediately after the procedure is complete | 
| X-ray exposure duration | Duration of flouroscopy exposure during the procedure | Immediately after the procedure is complete | 
| Length of hospital stay | Number of days that the patient will spend in the hospital after the procedure. | 7 days | 
| Complications at access site | Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural complications | Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis | 30 days |