Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma (CREATE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Aldosteronism; Aldosterone-Producing Adenoma
• Intervention / Treatment: Procedure: Endoscopic Ultrasound-Guided Ethanol Ablation

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shumin Yang, MD, PhD; Phone Number: +86-023-89011552; Email: ysm@hospital.cqmu.edu.cn
• Study Contact Backup: Name: Liang Deng, MD, PhD; Phone Number: +86-023-89011510; Email: dengliang@hospital.cqmu.edu.cn

Study Locations

• China
  • Choongqing
    • Chongqing, Choongqing, China, 400016
      • The First Affiliated Hospital of Chongqing Medical University
      • Contact: Shumin Yang, MD, PhD; Phone Number: +86 023-89011552; Email: ysm@hospital.cqmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of left-sided aldosterone-producing adrenal adenoma.
2. Unwillingness to undergo adrenalectomy or presence of contraindications to surgery.
3. Ability and willingness to provide written informed consent.

Exclusion Criteria:

1. History of alcohol allergy.
2. Inability to discontinue beta-blockers.
3. Inability to discontinue anticoagulants, antiplatelet agents, or glucocorticoids.
4. Platelet count <50 × 10^9/L or uncorrectable coagulation dysfunction.
5. Imaging findings suggestive of adrenal cyst, adrenal hematoma, or myelolipoma.
6. Presence of other active malignancies.
7. Pregnancy or breastfeeding; alcohol abuse; drug abuse; or mental disorder that may interfere with study participation.
8. 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.
9. Poor compliance or any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Endoscopic Ultrasound-Guided Ethanol Ablation; Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related major adverse events	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete tumor ablation on imaging	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	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	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

Collaborators and Investigators

• Sponsor: Chongqing Medical University
• Investigators: Principal Investigator: Shumin Yang, MD, PhD, First Affiliated Hospital of Chongqing Medical University; Principal Investigator: Liang Deng, MD, PhD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• Deng L, Hao Y, Zhang X, Li Q, Hu J, Yang S. Endoscopic ultrasound-guided ethanol ablation for aldosterone-producing adenoma. Endoscopy. 2026 Jun;58(S 02):E702-E703. doi: 10.1055/a-2875-0099. Epub 2026 Jun 11. No abstract available.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): July 15, 2029

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Endoscopic ultrasound; Primary aldosteronism; Aldosterone-producing adenoma; Ethanol ablation; EUS-guided ethanol ablation
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism; Adrenocortical Adenoma
• Other Study ID Numbers: 2026-0558-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No