Transfemoral Versus Transradial Partial Splenic Artery Embolization in Patients With Hypersplenism

NCT05446116 | Completed DMC

• 1 other identifier: Zu-IRB#9027/13-6-2021
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypersplenism

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Procedural complications

  30 days

Study Arms (2)

femoral puncture

ACTIVE COMPARATOR

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

Radial puncture

ACTIVE COMPARATOR

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

Interventions

partial splenic artery embolization PROCEDURE

embolization of the splenic artery for the treatment of hypersplenism

Radial puncture; femoral puncture

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Faculty of medicine, Zagazig university

Zagazig, Egypt

Location

MeSH Terms

Conditions

Hypersplenism

Condition Hierarchy (Ancestors)

Splenic Diseases; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mohamed MA Zaitoun, MD

  Zagazig University Radiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: July 6, 2022
• Study Start: June 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 18, 2021
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)