Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

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

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

Study Overview

• Status: Completed
• Conditions: Hypersplenism
• Intervention / Treatment: Procedure: partial splenic artery embolization

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Faculty of Medicine, Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with hypersplenism and severe thrombocytopenia (platelet count < 50,000/mm3).
2. 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).
3. Eligible for both femoral and radial puncture.

Exclusion Criteria:

1. Patients referred for embolization as treatment of traumatic splenic injury.
2. Patients lost during follow-up.

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: femoral puncture; 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; embolization of the splenic artery for the treatment of hypersplenism
Active Comparator: Radial puncture; 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; embolization of the splenic artery for the treatment of hypersplenism

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Mohamed MA Zaitoun, MD, Zagazig University Radiology Department

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 18, 2021

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Splenic Diseases; Hypersplenism
• Other Study ID Numbers: Zu-IRB#9027/13-6-2021

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No