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A prospective case-control, multicenter study of microwave ablation versus laparoscopic adrenal adenomatectomy for primary aldosteronism in unilateral adrenal adenomas

A prospective case-control, multicenter study of microwave ablation versus laparoscopic adrenal adenomatectomy for primary aldosteronism in unilateral adrenal adenomas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092395
Enrollment
Unknown
Registered
2024-11-15
Start date
2024-05-07
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary aldosteronism

Interventions

Primary aldosteronism:Microwave ablation
Primary aldosteronism:Laparoscopic adrenal adenomatectomy

Sponsors

Tianjin Medical University General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old and = 75 years old; 2. PA patients who can be diagnosed with primary aldosteronism (PA) according to the consensus of the 2020 version of China and meet the surgical indications for unilateral adrenal adenoma. (1) Age 3, and dominant side index (LI) > 4; b. Non-adrenocorticotropic hormone-stimulated AVS: SI > 2, and LI > 3, and contralateral inhibitory index (CSI) < 0.5/1. 3. Clinically judged to be suitable for microwave ablation therapy and adrenal surgery (as determined in MDT diagnosis and treatment), able and willing to give informed consent, and agree to undergo follow-up and undergo corresponding examinations during follow-up.

Exclusion criteria

Exclusion criteria: 1. Absolute contraindication to alpha or beta-adrenergic receptor antagonists, or inability to discontinue beta-adrenergic receptor antagonist therapy for 2 weeks; 2.Contraindications for adrenal adenoma microwave ablation or laparoscopic surgery, including: contrast agent allergy, severe heart failure (NYHA class III/IV), cerebrovascular structural abnormalities with bleeding risk, blood pressure >180/110 mmHg, and coagulopathy; 3. Pregnancy or unwillingness to use reliable contraception during the study (female participants only); 4.Life-limiting comorbidities (as determined by the Principal Investigator); 5. Co-secretion of cortisol (all participants will undergo a low-dose dexamethasone suppression test); 6. HIV infection and/or active tuberculosis infection; 7. Unwillingness to undergo microwave ablation therapy or adrenal surgery, or unwillingness to comply with the study visit schedule.

Design outcomes

Primary

MeasureTime frame
Aldosterone;Renin;ARR;Blood pressure;Types and doses of antihypertensive drugs;

Secondary

MeasureTime frame
Electrolyte;Renal function;

Countries

China

Contacts

Public ContactMing Liu

Tianjin Medical University General Hospital

mingliu@tmu.edu.cn+86 183 2201 7516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026