Aldosterone-Producing Adenoma, Primary Aldosteronism
Conditions
Keywords
Endoscopic ultrasound, Ethanol ablation, Aldosterone-producing adenoma, EUS-guided ethanol ablation, Primary aldosteronism
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.
Interventions
PROCEDUREEndoscopic Ultrasound-Guided Ethanol Ablation
Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
Sponsors
Chongqing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related major adverse events | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete tumor ablation on imaging | 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. |
| Complete biochemical remission rate | 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. |
| Complete clinical remission rate | 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. |
Countries
China
Contacts
CONTACTShumin Yang, MD, PhD
CONTACTLiang Deng, MD, PhD
PRINCIPAL_INVESTIGATORShumin Yang, MD, PhD
First Affiliated Hospital of Chongqing Medical University
PRINCIPAL_INVESTIGATORLiang Deng, MD, PhD
First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed