A Single-Arm Clinical Trial of Percutaneous Splenic Ablation Combined With Splenic Artery Occlusion for Secondary Hypersplenism.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: microwave ablation of the spleen, Splenic artery balloon implantation.
- Who it may be relevant to
- Registry conditions: Secondary Hypersplenism. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment
Overview
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
- Procedure microwave ablation of the spleen
Ultrasound-guided percutaneous puncture for splenic ablation treatment - Other Splenic artery balloon implantation
Splenic artery balloon implantation
Primary outcome measures
- Dynamic changes in platelet and white blood cell counts in routine blood tests [Time frame: Up to 1 year]
- Hepatic artery blood flow velocity [Time frame: Up to 1 year]
- Routine blood test [Time frame: Up to 1 year]
- Adverse Events [Time frame: Up to 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute & Hospital — Tianjin
Identifiers
NCT: NCT06292715 · Microwave Ablation01