Hypersplenism
Conditions
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.
Interventions
PROCEDUREpartial splenic artery embolization
embolization of the splenic artery for the treatment of hypersplenism
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural time | Immediately after the procedure is complete | The time interval from starting the anaethesia till completion of 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. |
| Average number of punctures | Immediately after the procedure is complete | Number of arterial punctures required to complete the procedure |
| Complications at access site | 30 days | Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding. |
| X-ray exposure duration | Immediately after the procedure is complete | Duration of flouroscopy exposure during the procedure |
| Length of hospital stay | 7 days | Number of days that the patient will spend in the hospital after the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural complications | 30 days | Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis |
Countries
Egypt
Outcome results
None listed