Radiofrequency Endoscopic Ablation With Ultrasound Guidance: a Non-surgical Treatment for Aldosterone-producing Adenomas

NCT03405025 | Completed DMC

• 1 other identifier: 222446
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief Summary

High blood pressure (hypertension) causes strokes and heart attacks. While most patients need long-term treatment with pills, some have a cause which can be removed, curing the hypertension. The commonest curable cause is a benign nodule in one of the hormone glands, the adrenals. About one in 20 patients have such a nodule, but difficulties with diagnosis, and reluctance to proceed to surgery for a benign condition, limit the number having adrenal gland surgery to fewer than 300 per year in the UK. A potential, and exciting, solution to this dilemma is to use a momentary electric current to cauterise the nodule (radiofrequency ablation), without affecting the rest of the adrenal gland, and avoiding the need for surgery. Nodules in the left adrenal gland are easily reached under mild sedation using a similar procedure as is standard for investigating stomach ulcers (endoscopy). The study is designed to show that this approach (endoscopic ultrasound guided radiofrequency ablation) is very safe, and to provide initial evidence that the hormone abnormality is cured.

Conditions

Primary Hyperaldosteronism; Primary Hyperaldosteronism Due to Adrenal Adenoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events of endoscopic ultrasound-guided radiofrequency ablation.

  The primary objective is to test the primary hypothesis which states that endoscopic ultrasound-guided radiofrequency ablation of aldosterone-producing adenomas of the adrenal gland is a safe method for achieving sustained reduction in plasma aldosterone. Specifically this will be assess via number of patients in whom one of the following is reported: 1. Major haemorrhage (seen on 24-48 hour safety CT) 2. Fall in Hb 3. Evidence of infarction of peri-adrenal organs on blood tests and CT 4. Evidence of rupture of stomach on CT

  24-48 hours post procedure

Secondary Outcomes (3)

• Evidence of 'biochemical cure' post endoscopic ultrasound-guided radiofrequency ablation

  6 months

• Evidence of 'radiological cure' post endoscopic ultrasound-guided radiofrequency ablation

  6 months

• Evidence of 'clinical cure' post endoscopic ultrasound-guided radiofrequency ablation

  6 months

Study Arms (1)

Safety and Feasibility

OTHER

All patients will undergo endoscopic US guided radiofrequency ablation, to assess safety and feasibility.

Procedure: Endoscopic ultrasound guided radiofrequency ablation; Device: ultrasound

Interventions

Endoscopic ultrasound guided radiofrequency ablation PROCEDURE

To establish if radiofreuqency ablation of aldosterone producing adrenal adenomas can be carried out via the endoscopic route and to assess safety of the procedure.

Safety and Feasibility

ultrasound DEVICE

ultrasound

Safety and Feasibility

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above
• Diagnosis of PHA based on published Endocrine Society guidelines
• Positive serum aldosterone renin ratio (ARR) with another local diagnostic confirmatory test (MRI or CT imaging)
• Group 1
• Left-sided APA proven on either AVS or PET CT.
• Patients wishing to take fewer drugs for their hypertension.
• Patients not usually referred for surgery because the benefit: risk is considered too low.
• Patients aged ≥60 whose BP is at or near target (BP140/90 for most patient groups, BP 130/80 if co-morbidities listed in Hypertension guidelines) on treatment with four or more drugs.
• patients with identified macroadenomas (APAs \>= 1 cm in diameter), who have at least 1 cm of peri-adrenal fat on axial and coronal projections.
• Group 2
• Patients aged 18 years and above with diagnosis of PA and either:
• \[i\] a definite unilateral left APA, but the patient does not want surgery; or \[ii\] probable but not unequivocal evidence of a unilateral left adrenal APA.
• Group 3 Patients over 18 years of age meeting criteria for surgery, but consent to undergo endoscopic ablation instead.

You may not qualify if:

• Inability to give informed consent.
• Any patients continuing on beta blockers/direct renin blockers.
• Pregnant women or those unable or unwilling to take secure contraceptive precautions.
• Any illness, condition or drug regimen considered a contraindication by the PI/CI.

Sponsors & Collaborators

• University College, London: lead
• Queen Mary University of London: collaborator
• British Heart Foundation: collaborator
• University of Cambridge: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• Barts & The London NHS Trust: collaborator
• University College London Hospitals: collaborator

Study Sites (3)

University of Cambridge and Cambridge NIHR Biomedical Research Centre

Cambridge, United Kingdom

Location

Queen Mary University of London

London, EC1M 6BQ, United Kingdom

Location

University College London

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hyperaldosteronism

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stephen Pereira

  University College, London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo the intervention: endoscopic ultra-sound guided radiofrequency ablation of their left adrenal aldosterone producing adenoma. The primary outcome is safety and feasibility

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: January 19, 2018
• Study Start: February 21, 2018
• Primary Completion: February 10, 2023
• Study Completion: May 10, 2023
• Last Updated: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Study protocol, SAP and ICF will be available within next 3-6 months and will remain available until close of study. The CSR will be available following statistical analysis.

Locations

GB (3)