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

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

Interventions

PROCEDURE

Endoscopic ultrasound guided radiofrequency ablation

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.

DEVICE

ultrasound

ultrasound

Sponsors & Collaborators

• Queen Mary University of London

  collaborator OTHER

• British Heart Foundation

  collaborator OTHER

• University of Cambridge

  collaborator OTHER

• Cambridge University Hospitals NHS Foundation Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• University College London Hospitals

  collaborator OTHER

• University College, London

  lead OTHER

Principal Investigators

• Stephen Pereira · University College, London

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-02-21

Primary Completion

2023-02-10

Completion

2023-05-10

Countries

• United Kingdom

Study Locations