Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism

Tianjin Medical University

Status: Enrolling

Conditions: Secondary Hypersplenism

Treatments: Other: Splenic artery balloon implantation; Procedure: microwave ablation of the spleen

Study type: Interventional

Funder types: Other

Identifiers

NCT06292715

Microwave Ablation01

Details and patient eligibility

About

This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.

Full description

This open-label, single-arm, single-center clinical trial investigates the combined approach of microwave ablation of the spleen and splenic artery occlusion for managing secondary hypersplenism.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. written informed consent signed prior to enrolment 2. age > 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells <3×109/L, and/or platelet <50×109/L 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism

Exclusion criteria

• Patients with any of the following are not eligible for enrollment in this study

  1. Coagulopathy or other blood disorders
  2. Recent use of anticoagulant drugs
  3. Severe hypertension and cardiac insufficiency
  4. Bone marrow aspiration results showed bone marrow suppression
  5. Combined with other spleen malignant diseases
  6. Severe skin infection at the puncture site
  7. Participated in other clinical studies within 2 months prior to the start of the study
  8. Patient or his/her authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

microwave ablation of the spleen combined with splenic artery occlusion

Experimental group

Description:

The ablation puncture needle is percutaneously punctured into the spleen under ultrasound guidance, and the ablation method of one needle and multi-point method and needle insertion and pulling is mostly used

Treatment:

Other: Splenic artery balloon implantation

Procedure: microwave ablation of the spleen