Comparing thermal ablation and adrenalectomy for treating primary aldosteronism
A Prospective Randomised Trial Comparing Thermal Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism
This study is testing whether a new treatment called thermal ablation works just as well as surgery for people with unilateral primary aldosteronism.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Queen Mary University of London Academic / other |
| Locations | 6 sites (Cambridge, SMLG and 5 other locations) |
| Trial ID | NCT05405101 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate whether thermal ablation is as effective as adrenalectomy in treating unilateral primary aldosteronism (PA). It will compare the biochemical and clinical outcomes of both interventions, focusing on factors such as adverse events, length of hospital stay, patient satisfaction, and quality of life. The study will also assess the anatomical efficacy of thermal ablation. Participants will be randomly assigned to receive either treatment, with the goal of determining the best approach for managing this condition.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 diagnosed with unilateral primary aldosteronism who meet specific imaging and clinical criteria.
Not a fit: Patients with bilateral adrenal hyperplasia or those unable to undergo either treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive treatment option for patients with unilateral primary aldosteronism.
How similar studies have performed: Previous studies have shown promising results for thermal ablation in similar conditions, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria (all of): * Age \> 18 years * Primary aldosteronism diagnosed according to international guidelines * Unilateral disease by AVS or PET-CT criteria * Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery * Able and willing to give informed consent * Randomisation approved by MDT Exclusion criteria (any of): * Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast * Contraindication or unwillingness for either surgery or thermal ablation * Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks * Unwilling to undergo either LA or thermal ablation * Unwilling to comply with study visit schedule * Pregnancy or unwillingness to undertake secure contraception for the study duration (female participants only) * Life-limiting comorbidity (at the discretion of the PI) * 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
Where this trial is running
Cambridge, SMLG and 5 other locations
- Cambridge University Hospitals NHS Foundation Trust — Cambridge, Smlg, United Kingdom (Recruiting)
- St Bartholomew's Hospital — London, United Kingdom (Recruiting)
- University College London Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Morris Brown — Queen Mary University of London
- Study coordinator: Aklima Khatun
- Email: aklima.khatun4@nhs.net
- Phone: 0203 765 8577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.