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
|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)|
|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|
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.
- 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:
- Major haemorrhage on CT
- Fall in Hb
- Evidence of infarction of peri-adrenal organs on blood tests and CT
- Evidence of rupture of stomach on CT
- 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.
- 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.
- 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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405025
|Contact: Stephen Pereira||+44 7918 firstname.lastname@example.org|
|Queen Mary University of London||Recruiting|
|London, United Kingdom, EC1M 6BQ|
|Contact: Morris Brown +44 2078823901 email@example.com|
|University College London||Recruiting|
|London, United Kingdom, NW3 2QG|
|Contact: Stephen Pereira +44 7918 030401 firstname.lastname@example.org|
|Principal Investigator:||Stephen Pereira||University College, London|