Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism

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

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

Study Overview

• Status: Recruiting
• Conditions: Secondary Hypersplenism
• Intervention / Treatment: Procedure: microwave ablation of the spleen; Other: Splenic artery balloon implantation

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 Type: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: WEI LU, PhD; Phone Number: 13820476460; Email: luwei1966@126.com

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China, 300060
      • Recruiting
      • Tianjin Medical University Cancer Institute & Hospital
      • Contact: Huikai Li; Phone Number: 3091 +862223340123; Email: lihuikai@tjmuch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: microwave ablation of the spleen combined with splenic artery occlusion; 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	Procedure: microwave ablation of the spleen; Ultrasound-guided percutaneous puncture for splenic ablation treatment; Other: Splenic artery balloon implantation; Splenic artery balloon implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Portal venous pressure	Portal venous pressure	Up to 1 year
Hepatic artery blood flow velocity	Hepatic artery blood flow velocity	Up to 1 year
Routine blood test	Platelet count	Up to 1 year
Adverse Events	Adverse Events	Up to 1 year

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: WEI LU, PhD, Tianjin Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 3, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Lymphatic Diseases; Neoplastic Processes; Splenic Diseases; Neoplasm Metastasis; Hypersplenism
• Other Study ID Numbers: Microwave Ablation01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No