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Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

Primary Purpose

Hypersplenism

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
partial splenic artery embolization
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypersplenism

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of medicine, Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

femoral puncture

Radial puncture

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Procedural complications
Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis

Full Information

First Posted
October 19, 2021
Last Updated
June 30, 2022
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05446116
Brief Title
Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism
Official Title
Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism, a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypersplenism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
femoral puncture
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Radial puncture
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
partial splenic artery embolization
Intervention Description
embolization of the splenic artery for the treatment of hypersplenism
Primary Outcome Measure Information:
Title
Technical Success of the Procedure
Description
The achievement of a single puncture allowing access to splenic artery without periprocedural complications.
Time Frame
Immediately after the procedure is complete
Title
Average number of punctures
Description
Number of arterial punctures required to complete the procedure
Time Frame
Immediately after the procedure is complete
Title
Procedural time
Description
The time interval from starting the anaethesia till completion of the procedure
Time Frame
Immediately after the procedure is complete
Title
X-ray exposure duration
Description
Duration of flouroscopy exposure during the procedure
Time Frame
Immediately after the procedure is complete
Title
Length of hospital stay
Description
Number of days that the patient will spend in the hospital after the procedure.
Time Frame
7 days
Title
Complications at access site
Description
Access site adverse events such as vessel thrombosis, pseudoaneurysm or bleeding.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Procedural complications
Description
Adverse events related to the procedure itself like splenic abscess, ascitis or portal vein thrombosis
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed MA Zaitoun, MD
Organizational Affiliation
Zagazig University Radiology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, Zagazig university
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

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