Superselective Renal Artery Embolization for Renal Angiomyolipoma

N/AActive Not RecruitingNCT07538908

Botkin Hospital50 enrolled

Overview

To evaluate the efficacy and safety of selective endovascular embolization in the treatment of renal angiomyolipoma (AML). Materials and Methods: A prospective analysis will be conducted on patients who undergo transcatheter renal artery embolization for renal angiomyolipoma. Inclusion criteria will be radiologically confirmed angiomyolipoma based on CT and/or MRI findings and the presence of clinical indications for embolization. The primary outcomes will include the assessment of changes in serum creatinine and hemoglobin levels post-procedure, technical success rates, and the incidence of any complications. Expected Results: Data on patient demographics, tumor characteristics, and procedural outcomes will be collected and analyzed. Conclusion: This study aims to determine whether selective endovascular embolization is a safe and effective treatment modality for renal angiomyolipoma, with the expectation of demonstrating a high rate of technical success while preserving renal function.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Selective Endovascular Embolization of Kidney Artery

Interventions

Selective endovascular embolization of kidney artery

Through arterial access (femoral, radial, or brachial), a catheter is advanced to the artery supplying the angiomyolipoma. Embolic agents used included Contour and Embosphere microspheres sized 50-710 μm. Blocking the blood vessels of the kidney that supply the tumor causes ischemia of the tumor, leading to stabilization of its growth and regression.Other Name

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: Renal angiomyolipoma confirmed by computed tomography or magnetic resonance imaging; Indications for surgical treatment (episodes of acute or recurrent bleeding, large tumor size, high risk of abdominal trauma due to specific lifestyle and working conditions, planned pregnancy in women, and limited access to emergency medical care); The patient's informed consent to undergo minimally invasive intervention, formed after being explained the nature of the disease, potential risks, alternative treatment methods, and expected outcomes. Exclusion Criteria: Angiomyolipoma of a solitary kidney; Severe renal failure (CKD stage 3a or higher); Pregnancy or lactation; Allergy to contrast agents or other drugs used during embolization; Coagulopathies or hemostatic disorders not amenable to correction;• Active urinary tract infection; Suspicion of malignant transformation (angiomyoliposarcoma) based on CT/MRI data or the presence of a malignant kidney tumor concurrently with AML; Non-operability or impossibility of catheterizing the feeding vessels (based on angiography); Patient's mental status preventing adequate decision-making and reducing the level of self-care;• Patient's unwillingness to participate in the study.

Outcomes

Primary Outcomes

Stopping the blood supply to the angiomyolipoma

After performing selective embolization of the renal vessel, the blood supply to the renal angiomyolipoma should be completely stopped. At the same time, post-embolization complications should be minimized, and kidney function should not be impaired. The result must be confirmed by instrumental imaging.

Time frame: 1-3 days

Secondary Outcomes

Reduction in the size of the angiomyolipoma.

One year later, on a follow-up computed tomography scan, a decrease in the size of the angiomyolipoma should be noted.

Time frame: 1 year