Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma
CREATE
1 other identifier
interventional
30
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2026
CompletedFirst Posted
Study publicly available on registry
July 14, 2026
CompletedStudy Start
First participant enrolled
July 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 15, 2029
July 14, 2026
July 1, 2026
2.5 years
July 9, 2026
July 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (1)
Endoscopic Ultrasound-Guided Ethanol Ablation
EXPERIMENTALParticipants with left-sided unilateral aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
Interventions
Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Choongqing, 400016, China
Related Publications (1)
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.
PMID: 42276127RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 9, 2026
First Posted
July 14, 2026
Study Start
July 15, 2026
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
July 15, 2029
Last Updated
July 14, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be made publicly available.