Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChongqing Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Endoscopic Ultrasound-Guided Ethanol Ablation
Procedure/SurgeryParticipants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Endoscopic Ultrasound-Guided Ethanol AblationExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Within 24-48 hours after endoscopic ultrasound-guided ethanol ablationSecondary outcomes
1
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.
Time frame
6 months after endoscopic ultrasound-guided ethanol ablation2
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.
Time frame
6 months after endoscopic ultrasound-guided ethanol ablation3
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.
Time frame
6 months after endoscopic ultrasound-guided ethanol ablationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chongqing Medical University
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov
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