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A Single-Arm Clinical Trial of Percutaneous Splenic Ablation Combined 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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06292715
Enrollment
35
Registered
2024-03-05
Start date
2024-01-20
Completion date
2026-12-31
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hypersplenism

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.

Interventions

PROCEDUREmicrowave ablation of the spleen

Ultrasound-guided percutaneous puncture for splenic ablation treatment

OTHERSplenic artery balloon implantation

Splenic artery balloon implantation

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamic changes in platelet and white blood cell counts in routine blood testsUp to 1 yearPlatelet and WBC count changes on CBC
Hepatic artery blood flow velocityUp to 1 yearHepatic artery blood flow velocity
Routine blood testUp to 1 yearPlatelet count
Adverse EventsUp to 1 yearAdverse Events

Countries

China

Contacts

CONTACTWEI LU, PhD
luwei1966@126.com13820476460
PRINCIPAL_INVESTIGATORWEI LU, PhD

Tianjin Cancer Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026