Endoscopic Ultrasound-Guided Ethanol Ablation of Aldosterone-Producing Adenomas
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Procedure-related major adverse events
研究概览
简要总结
This is a prospective, single-center, single-arm study evaluating endoscopic ultrasound-guided ethanol ablation for left-sided aldosterone-producing adenoma. Eligible participants will receive the ablation procedure and be followed for safety, imaging response, biochemical remission, and clinical remission. The study is expected to enroll 30 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Diagnosis of left-sided aldosterone-producing adrenal adenoma.
- •Unwillingness to undergo adrenalectomy or presence of contraindications to surgery.
- •Ability and willingness to provide written informed consent.
排除标准
- •History of alcohol allergy.
- •Inability to discontinue beta-blockers.
- •Inability to discontinue anticoagulants, antiplatelet agents, or glucocorticoids.
- •Platelet count <50 × 10^9/L or uncorrectable coagulation dysfunction.
- •Imaging findings suggestive of adrenal cyst, adrenal hematoma, or myelolipoma.
- •Presence of other active malignancies.
- •Pregnancy or breastfeeding; alcohol abuse; drug abuse; or mental disorder that may interfere with study participation.
- •Severe comorbid conditions, including any of the following: New York Heart Association (NYHA) class III-IV heart failure or hospitalization for worsening chronic heart failure within the previous 3 months; stroke or acute coronary syndrome within the previous 3 months; severe anemia (hemoglobin <60 g/L); severe hepatic disease (alanine aminotransferase ≥3 × the upper limit of normal); severe renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²; systemic inflammatory response syndrome (SIRS); poorly controlled diabetes mellitus (fasting blood glucose ≥13.3 mmol/L); severe obesity (body mass index ≥35 kg/m²); untreated aneurysm; or any other severe medical condition that may interfere with treatment or study follow-up.
- •Poor compliance or any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.
研究组 & 干预措施
Endoscopic Ultrasound-Guided Ethanol Ablation
Participants with left-sided unilateral aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
干预措施: Endoscopic Ultrasound-Guided Ethanol Ablation (Procedure)
结局指标
主要结局
Procedure-related major adverse events
时间窗: Within 24-48 hours after endoscopic ultrasound-guided ethanol ablation
Assessment of predefined procedure-related major adverse events occurring within 24-48 hours after endoscopic ultrasound-guided ethanol ablation, including imaging-confirmed major bleeding, gastrointestinal perforation, major organ infarction, and hypertensive urgency or emergency (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg).
次要结局
- Complete tumor ablation on imaging(6 months after endoscopic ultrasound-guided ethanol ablation)
- Complete biochemical remission rate(6 months after endoscopic ultrasound-guided ethanol ablation)
- Complete clinical remission rate(6 months after endoscopic ultrasound-guided ethanol ablation)
研究者
Shumin Yang
Professor
First Affiliated Hospital of Chongqing Medical University