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Trial record 33 of 300 for:    Recruiting, Not yet recruiting, Available Studies | "Adenoma"

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

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ClinicalTrials.gov Identifier: NCT03405025
Recruitment Status : Recruiting
First Posted : January 19, 2018
Last Update Posted : May 25, 2018
Sponsor:
Collaborators:
Queen Mary University of London
British Heart Foundation
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Barts & The London NHS Trust
University College London Hospitals
Information provided by (Responsible Party):
University College, London

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 bengin 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.

Condition or disease Intervention/treatment Phase
Primary Hyperaldosteronism Primary Hyperaldosteronism Due to Adrenal Adenoma Procedure: Endoscopic ultrasound guided radiofrequency ablation Device: ultrasound Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility Study of RadioFrequency Endoscopic ABlation, With ULtrasound Guidance, as a Non-surgical, Adrenal Sparing Treatment for Aldosterone-producing Adenomas
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : January 28, 2021
Estimated Study Completion Date : July 28, 2022


Arm Intervention/treatment
Safety and Feasibility
All patients will undergo endoscopic US guided radiofrequency ablation, to assess safety and feasibility.
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




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events of endoscopic ultrasound-guided radiofrequency ablation. [ Time Frame: 48 hours post procedure ]

    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 on 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

  2. Efficacy of endoscopic ultrasound-guided radiofrequency ablation [ Time Frame: 3 months ]
    The second co-primary end point is efficacy of endoscopic radifrequency ablation. This will be assess based on biochemical cure of primary hyperaldosteronism at 3 months, via measurement of plasma potassium, aldosterone and renin levels.


Secondary Outcome Measures :
  1. Evidence of 'biochemical cure' post endoscopic ultrasound-guided radiofrequency ablation [ Time Frame: 6 months ]
    Difference in measurement of plasma electrolytes, renin and aldosterone at baseline and 6 months following ablation looking for normalisation post procedure.

  2. Evidence of 'radiological cure' post endoscopic ultrasound-guided radiofrequency ablation [ Time Frame: 6 months ]
    Metomidate PET CT will be performed at 6 months after ablation and compared with baseline PET CT looking for 'radiological cure', ie successful ablation of previous 'hot' aldosterone producing adrenal adenoma.

  3. Evidence of home BP improvement post endoscopic ultrasound-guided radiofrequency ablation [ Time Frame: 6 months ]
    Difference in Home BP measurements (3 readings morning and 3 in the evening for 4 days) before clinic visits at baseline and at 6 months.

  4. Evidence of clinic BP improvement post endoscopic ultrasound-guided radiofrequency [ Time Frame: 6 months ]
    Difference in BP measurements in clinic at baseline and 6 months following ablation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 18 and above
  2. Diagnosis of PHA based on published Endocrine Society guidelines
  3. Positive serum aldosterone renin ratio (ARR) with another local diagnostic confirmatory test (MRI or CT imaging)

There are 3 inclusion subset groups:

Group 1

  1. Left-sided APA proven on either AVS or PET CT.
  2. Patients wishing to take fewer drugs for their hypertension.
  3. Patients not usually referred for surgery because the benefit: risk is considered too low.
  4. 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.
  5. 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405025


Contacts
Contact: Stephen Pereira +44 7918 030401 stephen.pereira@ucl.ac.uk

Locations
United Kingdom
Queen Mary University of London Recruiting
London, United Kingdom, EC1M 6BQ
Contact: Morris Brown    +44 2078823901    morris.brown@qmul.ac.uk   
University College London Recruiting
London, United Kingdom, NW3 2QG
Contact: Stephen Pereira    +44 7918 030401    stephen.pereira@ucl.ac.uk   
Sponsors and Collaborators
University College, London
Queen Mary University of London
British Heart Foundation
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Barts & The London NHS Trust
University College London Hospitals
Investigators
Principal Investigator: Stephen Pereira University College, London

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03405025     History of Changes
Other Study ID Numbers: 222446
First Posted: January 19, 2018    Key Record Dates
Last Update Posted: May 25, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Please see below
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Adenoma
Adrenocortical Adenoma
Hyperaldosteronism
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Cortex Diseases