The First Affiliated Hospital of Chongqing Medical University
Chongqing, Choongqing, 400016, China
NCT Number: NCT07700472
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Chongqing, Choongqing, 400016, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Liang Deng, MD, PhD
CONTACT
Shumin Yang, MD, PhD
CONTACT
Chongqing Medical University
Other
Endoscopic Ultrasound-Guided Ethanol Ablation of Aldosterone-Producing Adenomas
Acronym: CREATE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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