Microwave ablation and artery occlusion for treating secondary hypersplenism
A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment
This study is testing a new treatment that combines microwave heat and blocking a blood vessel to help people with severe hypersplenism related to cirrhosis who haven't found relief with standard therapies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT06292715 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a combined treatment approach involving microwave ablation of the spleen and splenic artery occlusion for patients suffering from secondary hypersplenism. It is an open-label, single-arm, single-center trial conducted at Tianjin Medical University Cancer Institute and Hospital. The study aims to provide a new therapeutic option for patients who have not responded well to conventional treatments for severe hypersplenism associated with cirrhosis.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe hypersplenism secondary to cirrhosis and poor response to previous treatments.
Not a fit: Patients with coagulopathy, severe hypertension, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve blood cell counts and overall health for patients with severe secondary hypersplenism.
How similar studies have performed: While this approach is innovative, there is limited data on similar combined interventions specifically for secondary hypersplenism.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Tianjin, Tianjin Municipality
- Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Principal investigator: WEI LU, PhD — Tianjin Cancer Hospital
- Study coordinator: WEI LU, PhD
- Email: luwei1966@126.com
- Phone: 13820476460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.