Primary AldosteronismCREATENCT07700472
Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma
A study testing Endoscopic Ultrasound-Guided Ethanol Ablation in people with Primary Aldosteronism and Aldosterone-Producing Adenoma, run by Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Aldosteronism, Aldosterone-Producing Adenoma
- What is being tested?
- Endoscopic Ultrasound-Guided Ethanol Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 15 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Choongqing, 400016
Shumin Yang, MD, PhD, +86 023-89011552, ysm@hospital.cqmu.edu.cn
About this study
Official title: 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.
- Being tested
- Endoscopic Ultrasound-Guided Ethanol Ablation
- Keywords
- Endoscopic ultrasound, Ethanol ablation, Aldosterone-producing adenoma, EUS-guided ethanol ablation, Primary aldosteronism
- Medical subject headings
- Hyperaldosteronism, Adrenocortical Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Ultrasound-Guided Ethanol AblationProcedure or surgery
Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic Ultrasound-Guided Ethanol Ablation | Experimental | Participants with left-sided unilateral aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance. Receives: Procedure: Endoscopic Ultrasound-Guided Ethanol Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 24-48 hours after endoscopic ultrasound-guided ethanol ablation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months after endoscopic ultrasound-guided ethanol ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion15 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shumin Yang, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Shumin Yang, MD, PhD, Principal investigator, First Affiliated Hospital of Chongqing Medical UniversityLiang Deng, MD, PhD, Principal investigator, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700472
- Sponsor's protocol ID
- 2026-0558-01
- Acronym
- CREATE
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available.
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.
PubMed 42276127
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-Guided Ethanol Ablation of Aldosterone-Producing Adenomas
- ClinicalTrials.gov ID
- NCT07700472
- Acronym / sponsor ID
- CREATE / 2026-0558-01
- Keywords
- Endoscopic ultrasound, Ethanol ablation, Aldosterone-producing adenoma, EUS-guided ethanol ablation, Primary aldosteronism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 15 Jul 2029 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic Ultrasound-Guided Ethanol Ablation | Experimental | Procedure: Endoscopic Ultrasound-Guided Ethanol AblationParticipants with left-sided unilateral aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Ultrasound-Guided Ethanol AblationParticipants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance. | Procedure or surgery | Endoscopic Ultrasound-Guided Ethanol Ablation |
Primary outcome
Procedure-related major adverse events
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).
3 secondary outcomes
Complete tumor ablation on imaging
Time frame: 6 months after endoscopic ultrasound-guided ethanol ablation
Complete biochemical remission rate
Time frame: 6 months after endoscopic ultrasound-guided ethanol ablation
Complete clinical remission rate
Time frame: 6 months after endoscopic ultrasound-guided ethanol ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 42276127Deng 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shumin Yang, MD, PhD principal investigator
First Affiliated Hospital of Chongqing Medical University
Liang Deng, MD, PhD principal investigator
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Ultrasound-Guided Ethanol Ablation in people with Primary Aldosteronism and Aldosterone-Producing Adenoma, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shumin Yang, MD, PhD (+86-023-89011552, ysm@hospital.cqmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure-related major adverse events (time frame: Within 24-48 hours after endoscopic ultrasound-guided ethanol ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07700472, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.