Endovascular Superselective Embolization of the Branches of the Renal Artery in the Treatment of Renal Angiomyolipoma: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Stopping the blood supply to the angiomyolipoma
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with angiomyolipoma
Patients with angiomyolipoma meeting the inclusion criteria for the study
干预措施: Selective endovascular embolization of kidney artery (Procedure)
结局指标
主要结局
Stopping the blood supply to the angiomyolipoma
时间窗: 1-3 days
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.
次要结局
- Reduction in the size of the angiomyolipoma.(1 year)
研究者
Drozdov Pavel
Senior Researcher
Botkin Hospital