Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma (CREATE)
2026年7月9日 更新者:Shumin Yang、Chongqing Medical University
Endoscopic Ultrasound-Guided Ethanol Ablation of Aldosterone-Producing Adenomas
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.
研究概览
研究类型
介入性
注册 (估计的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Shumin Yang, MD, PhD
- 电话号码:+86-023-89011552
- 邮箱:ysm@hospital.cqmu.edu.cn
研究联系人备份
- 姓名:Liang Deng, MD, PhD
- 电话号码:+86-023-89011510
- 邮箱:dengliang@hospital.cqmu.edu.cn
学习地点
-
-
Choongqing
-
Chongqing、Choongqing、中国、400016
- The First Affiliated Hospital of Chongqing Medical University
-
接触:
- Shumin Yang, MD, PhD
- 电话号码:+86 023-89011552
- 邮箱:ysm@hospital.cqmu.edu.cn
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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.
|
Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Procedure-related major adverse events
大体时间: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).
|
Within 24-48 hours after endoscopic ultrasound-guided ethanol ablation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Complete tumor ablation on imaging
大体时间:6 months after endoscopic ultrasound-guided ethanol ablation
|
Complete radiologic ablation will be assessed by PET/CT at 6 months after endoscopic ultrasound-guided ethanol ablation.
Complete ablation is defined as no abnormal radiotracer uptake in the treated adrenal lesion.
|
6 months after endoscopic ultrasound-guided ethanol ablation
|
|
Complete biochemical remission rate
大体时间:6 months after endoscopic ultrasound-guided ethanol ablation
|
The proportion of participants with complete biochemical remission at 6 months after endoscopic ultrasound-guided ethanol ablation will be assessed according to the PASO consensus criteria.
Complete biochemical remission is defined as normalization of serum potassium and aldosterone-to-renin ratio, or normalization of serum potassium with suppressed aldosterone secretion on confirmatory testing, defined as post-SSIT aldosterone <80 pg/mL or post-CCT aldosterone <110 pg/mL.
|
6 months after endoscopic ultrasound-guided ethanol ablation
|
|
Complete clinical remission rate
大体时间:6 months after endoscopic ultrasound-guided ethanol ablation
|
The proportion of participants with complete clinical remission at 6 months after endoscopic ultrasound-guided ethanol ablation will be assessed according to the PASO consensus criteria.
Complete clinical remission is defined as normal blood pressure without any antihypertensive medication.
|
6 months after endoscopic ultrasound-guided ethanol ablation
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Shumin Yang, MD, PhD、First Affiliated Hospital of Chongqing Medical University
- 首席研究员:Liang Deng, MD, PhD、First Affiliated Hospital of Chongqing Medical University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月15日
初级完成 (估计的)
2028年12月31日
研究完成 (估计的)
2029年7月15日
研究注册日期
首次提交
2026年7月9日
首先提交符合 QC 标准的
2026年7月9日
首次发布 (实际的)
2026年7月14日
研究记录更新
最后更新发布 (实际的)
2026年7月14日
上次提交的符合 QC 标准的更新
2026年7月9日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- 2026-0558-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
Individual participant data (IPD) will not be made publicly available.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.