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NCT Number: NCT07700472

Endoscopic Ultrasound-Guided Ethanol Ablation for Aldosterone-Producing Adenoma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Choongqing, 400016, China

Location contact

Shumin Yang, MD, PhD

CONTACT

[email protected]

+86 023-89011552

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Endoscopic Ultrasound-Guided Ethanol Ablation

Procedure

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Complete tumor ablation on imaging

    Time frame: 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.

  2. Complete biochemical remission rate

    Time frame: 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.

  3. Complete clinical remission rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Deng, MD, PhD

CONTACT

[email protected]

+86-023-89011510

Shumin Yang, MD, PhD

CONTACT

[email protected]

+86-023-89011552

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study title

Endoscopic Ultrasound-Guided Ethanol Ablation of Aldosterone-Producing Adenomas

Acronym: CREATE

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 14, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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