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A clinical trial to explore the usefulness of partial splenic artery embolization using n-butyl-2-cyanoacrylate compared with metal coils in patients with hypersplenism Phase II study

A clinical trial to explore the usefulness of partial splenic artery embolization using n-butyl-2-cyanoacrylate compared with metal coils in patients with hypersplenism Phase II study

Kato Jun

Chiba University Hospital

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Pref ecture

takakon@chiba-u.jp

Unozawa Hidemi

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Pref ecture

1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Pref ecture

+81-432227171

unozawa.hidemi@chiba-u.jp

Recruiting

May. 07, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

Patients who meet all of the following criteria will be included in the study:

1) Adults aged 20 years or older at the time of obtaining consent

2) Patients with hypersplenism who are candidates for partial splenic embolization(PSE)

3) Patients with a platelet count of less than 100000

4) Patients who have been given a full explanation of their participation in this study, have fully understood the subject, and have given their own voluntary written consent

/Those who meet any of the following criteria will not be eligible to participate:

1) Patients with severe contrast allergies

2) Patients with past hypersensitivity to cyanoacrylate drugs

3) Patients who are pregnant, possibly pregnant, within 28 days of giving birth, or breastfeeding

4) Patients with poor general condition due to infection or other conditions that affect platelet counts

5) Patients who have received platelet transfusions or used thrombopoietin receptor agonists within one month prior to the start of the study

6) Patients with blood disorders that affect platelet counts

7) Patients currently undergoing anticancer drug treatment

8) Patients who are otherwise deemed unsuitable for the safe implementation of this study by the principal investigator or co-investigator

Both

Hypersplenism

Test drug treatment group: Partial splenic artery embolization was performed using n-butyl-2-cyanoacrylate.
Control group: Partial splenic artery embolization was performed using metal coils.

Post-treatment platelet increase: The increase in platelet count during the follow-up period compared to the platelet count during the screening period

Secondary endpoint
Secondary endpoint for efficacy
[Secondary endpoint for efficacy]
Post-treatment platelet increase: The number of platelet increases during the study intervention period compared to the platelet count during the screening period

Treatment costs for platelet increase (number of NBCA vials, number of metal coils used, number of catheters)

Embolization rate of splenic artery: Embolization volume during the follow-up period on CT/spleen volume during the follow-up period (%)

Treatment time (Time required from reaching the target blood vessel to completing embolization)

Secondary safety endpoints
Frequency of adverse events: Post-embolization syndrome (abdominal pain, fever), splenic abscess, pleural and abdominal effusion, splenic rupture, sepsis, disseminated intravascular coagulation, pancreatic necrosis, catheter-related adverse events (difficulty or inability to remove catheter due to NBCA, vascular damage)

+81-43-226-2616

April. 21, 2025

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