Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

Hypersplenism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05446116
• Other study ID #: Zu-IRB#9027/13-6-2021
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: October 18, 2021

Study information

• Verified date: June 2022
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: October 18, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypersplenism

Intervention

Procedure:
• partial splenic artery embolization
embolization of the splenic artery for the treatment of hypersplenism

Locations

Country	Name	City	State
Egypt	Faculty of medicine, Zagazig university	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Average number of punctures	Number of arterial punctures required to complete the procedure	Immediately after the procedure is complete
Primary	Procedural time	The time interval from starting the anaethesia till completion of the procedure	Immediately after the procedure is complete
Primary	X-ray exposure duration	Duration of flouroscopy exposure during the procedure	Immediately after the procedure is complete
Primary	Length of hospital stay	Number of days that the patient will spend in the hospital after the procedure.	7 days
Primary	Complications at access site	Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.	30 days
Secondary	Procedural complications	Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis	30 days