Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism

Not Applicable

Recruiting

• Conditions: Secondary Hypersplenism
• Interventions: Procedure: microwave ablation of the spleen; Other: Splenic artery balloon implantation

• Registration Number: NCT06292715
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-01-20
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-03-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-05
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
microwave ablation of the spleen combined with splenic artery occlusion	Splenic artery balloon implantation	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
microwave ablation of the spleen combined with splenic artery occlusion	microwave ablation of the spleen	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

Primary Outcome Measures

Name	Time	Method
Portal venous pressure	Up to 1 year	Portal venous pressure
Hepatic artery blood flow velocity	Up to 1 year	Hepatic artery blood flow velocity
Routine blood test	Up to 1 year	Platelet count
Adverse Events	Up to 1 year	Adverse Events

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute & Hospital; 🇨🇳 Tianjin, Tianjin, China