NCT07700472

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

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
36mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jul 2026Jul 2029

First Submitted

Initial submission to the registry

July 9, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

July 15, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2029

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

Endoscopic ultrasoundEthanol ablationAldosterone-producing adenomaEUS-guided ethanol ablationPrimary aldosteronism

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

EXPERIMENTAL

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

Interventions

Participants with left-sided aldosterone-producing adenoma undergo endoscopic ultrasound-guided ethanol ablation under real-time endoscopic ultrasound guidance.

Endoscopic Ultrasound-Guided Ethanol Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

Related Links

MeSH Terms

Conditions

HyperaldosteronismAdrenocortical Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesAdrenal Cortex NeoplasmsAdrenal Gland NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsAdrenal Cortex Diseases

Study Officials

  • Shumin Yang, MD, PhD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR
  • Liang Deng, MD, PhD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

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.

Locations