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NCT Number: NCT06292715

A Single-Arm Clinical Trial of Percutaneous Splenic Ablation Combined With Splenic Artery Occlusion for Secondary Hypersplenism.

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location status: Recruiting

Location contact

Huikai Li

CONTACT

[email protected]

+862223340123 ext. 3091

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microwave ablation of the spleen

Procedure

Ultrasound-guided percutaneous puncture for splenic ablation treatment

Splenic artery balloon implantation

Other

Splenic artery balloon implantation

Primary outcomes

  1. Dynamic changes in platelet and white blood cell counts in routine blood tests

    Time frame: Up to 1 year

    Platelet and WBC count changes on CBC

  2. Hepatic artery blood flow velocity

    Time frame: Up to 1 year

    Hepatic artery blood flow velocity

  3. Routine blood test

    Time frame: Up to 1 year

    Platelet count

  4. Adverse Events

    Time frame: Up to 1 year

    Adverse Events

Study contacts

Contact information is provided by the study sponsor or research team.

WEI LU, PhD

CONTACT

[email protected]

13820476460

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.