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Trial Title:
Microwave Ablation With Splenic Artery Occlusion for Secondary Hypersplenism
NCT ID:
NCT06292715
Condition:
Secondary Hypersplenism
Conditions: Official terms:
Neoplasm Metastasis
Hypersplenism
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
microwave ablation of the spleen
Description:
Ultrasound-guided percutaneous puncture for splenic ablation treatment
Arm group label:
microwave ablation of the spleen combined with splenic artery occlusion
Intervention type:
Other
Intervention name:
Splenic artery balloon implantation
Description:
Splenic artery balloon implantation
Arm group label:
microwave ablation of the spleen combined with splenic artery occlusion
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.
Criteria for 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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Huikai Li
Phone:
+862223340123
Phone ext:
3091
Email:
lihuikai@tjmuch.com
Start date:
January 20, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06292715
