A Prospective Randomised Trial Comparing Thermal Ablation With Laparoscopic Adrenalectomy as an alternatiVE Treatment for Unilateral Asymmetric Primary Aldosteronism

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria. Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought. * Frequency and severity of adverse events * Length of inpatient stay * Patient satisfaction * Quality of life * Return to activities of daily living An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Guy's and St Thomas' NHS Foundation Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
University College London Hospital NHS Foundation Trust
RECRUITING
London
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Aklima Khatun
aklima.khatun4@nhs.net
0203 765 8577
Backup
Tumi Kaminsas
research.governance@qmul.ac.uk
0207 882 5994
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 122
Treatments
Experimental: Thermal ablation of adrenal aldosterone producing adenoma (s)
For patients randomized to ablation, thermal ablation (either microwave or radiofrequency ablation) will be deployed to treat the adrenal aldosterone producing adenoma(s)
Other: Unilateral adrenalectomy for aldosterone producing adenoma (s)
For patients randomized to surgery, unilateral adrenalectomy will be performed to remove aldosterone producing adenoma(s)
Related Therapeutic Areas
Sponsors
Leads: Queen Mary University of London

This content was sourced from clinicaltrials.gov