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
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
|Contact: Stephen Pereira||+44 7918 email@example.com|
|Queen Mary University of London||Recruiting|
|London, United Kingdom, EC1M 6BQ|
|Contact: Morris Brown +44 2078823901 firstname.lastname@example.org|
|University College London||Recruiting|
|London, United Kingdom, NW3 2QG|
|Contact: Stephen Pereira +44 7918 030401 email@example.com|
|Principal Investigator:||Stephen Pereira||University College, London|