Random comparison of keyhole surgery versus cauterisation of aldosterone-producing adenomas in primary aldosteronism

Not Applicable

• Conditions: Primary aldosteronism; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11531672
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-26
• Last Update Posted: 8 July 2024
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Current participant inclusion criteria as of 17/06/2024:
All of the following Participant inclusion criteria:
1. Age > 18 years
2. Primary aldosteronism diagnosed according to international guidelines
3. Unilateral disease by AVS or PET-CT criteria
4. Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery
5. Able and willing to give informed consent
6. Randomisation approved by MDT

Previous participant inclusion criteria:
1. Age >18 years
2. Primary aldosteronism according to international guidelines:
2.1. An elevated aldosterone renin ratio (according to local reference ranges), and at least one of the following (when measured off confounding medications):
2.1.1. Spontaneous or diuretic-induced hypokalaemia
2.1.2. A positive saline infusion test (SIT)
3. Four-hour aldosterone >190 pmol/L
4. A positive captopril suppression test (CST), either:
4.1. Failure to suppress two-hour aldosterone by >30% and persistent suppression of plasma renin activity/mass
4.2. Two-hour aldosterone >300 pmol/L14
4.3. Unilateral PA, defined by at least one of the following criteria:
5. ACTH-stimulated AVS24
5.1. Selectivity index (SI) >3, and
5.2. Lateralisation index (LI) >4
6. Non-ACTH-stimulated AVS24:
6.1. SI > 2, and
6.2. LI > 3, and
6.3. Contralateral suppression index (CSI) < 0.5/1
7. Metomidate/CETO PET-CT scan
7.1. >25% higher PET signal (maximum standardised uptake value) over an adenoma compared to the contralateral adrenal
8. Age <35 years, unilateral adrenal lesion with normal contralateral gland
9. Radiological abnormality ipsilateral to the side of lateralisation, which is:
9.1. Benign:
9.1.1. Unenhanced CT attenuation <20HU, or
9.1.2. Post-contrast CT absolute washout >60%, or
9.1.3. Post-contract CT relative washout >40%, or
9.1.4. Signal drop-out on out-of-phase MRI
9.2. Technically amenable to both RFA and surgery (determined at MDT review)
10. Able and willing to give informed consent

Exclusion Criteria

Current participant exclusion criteria as of 17/06/2024:
1. Absolute contraindication to a- or ß-adrenoceptor antagonist therapy or CT contrast
2. Contraindication or unwillingness for either surgery or thermal ablation
3. Inability to withdraw ß-adrenoceptor antagonist therapy for 2 weeks
4. Unwilling to undergo either LA or thermal ablation
5. Unwilling to comply with study visit schedule
6. Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only)
7. Life-limiting comorbidity (at the discretion of the PI)
8. Clinical and/or biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion

Previous participant exclusion criteria:
1. Absolute contraindication to a- or ß-adrenoceptor antagonist therapy or CT contrast
2. Contraindication or unwillingness for either surgery or RFA
3. Inability to withdraw ß-adrenoceptor antagonist therapy for 2 weeks
4. Unwilling to undergo either LA or RFA
5. Unwilling to comply with study visit schedule
6. Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only)
7. Life-limiting comorbidity (at the discretion of the PI)
8. Clinical and/or biochemical evidence of autonomous cortisol secretion sufficient, in the opinion of the patient's physician, to mandate a unilateral adrenalectomy independent of autonomous aldosterone secretion

Study & Design

• Study Type: Interventional
• Study Design: Not specified