Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

Not Applicable

Completed

• Conditions: Hypersplenism
• Interventions: Procedure: partial splenic artery embolization

• Registration Number: NCT05446116
• Lead Sponsor: Zagazig University

Brief Summary

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

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 Timeline

• Study Start: 2019-06-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-18
• Study First Submitted: 2021-10-19
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial puncture	partial splenic artery embolization	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.
femoral puncture	partial splenic artery embolization	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Procedural complications	30 days	Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis

Trial Locations

Locations (1)

Faculty of medicine, Zagazig university; 🇪🇬 Zagazig, Egypt