UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Title of the study (Brief title)	Exploratory trial of radiofrequency ablation therapy for primary aldosteronism patients
Region	Japan

Condition
Condition	primary aldosteronism caused by unilateral aldosterone hyper secretion
Classification by specialty	Endocrinology and Metabolism Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of percutaneous radiofrequency ablation therapy for unilateral aldosterone producing adenoma in normalizing aldosterone secretion.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	aldosterone level in serum and 24-hour urine collection 7 days after ablation therapy
Key secondary outcomes	1. Clinical laboratory test ACTH, cortisol, serum aldosterone, renin activity, ARR, serum TTKG, osmotic pressure and pottasium level, urine osmolality 2. Antihypertensive medication Dose at screening and 84 days after ablation therapy 3. Ablation effect evaluation by enhanced computed tomography 7 days after treatment.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	CT guided radiofrequency ablation is performed with total power of 4-6kJ for aldosterone producing adrenal adenoma which is proven as unilateral functioning adenoma by adrenal venous sampling.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Equal or more than 20 years old at the time of informed concent. 2. Agreement with written informed concent. 3. Primary aldosteronism with unilateral functioning macroadenoma with following conditions: a. CT detectable adenoma without any risky organs on a puncture route. b. Intervening adipose tissue between target adenoma and adjacent risky organs(pancreas or intestine). c. Adenoma diameter between 5 and 25mm. d. Unilateral single functioning macroadenoma with aldosterone hypersecretion proven by adrenal venous sampling. e. Enough major organic function with following labolatory datas at screening: WBC>=3000/mm3 Plt>=100,000/mm3, Hb>=8.0 g/dl,eGFR>=45mL/min/1.73m2 f. PS=0-2
Key exclusion criteria	1. Pasemaker or ICD implantation 2. Possibilities of malignancy 3. impaired blood clotting with PT-INR>=2.0 4. Possibilities of infection 5. Intolerance to acute blood pressure change: a. Abdominal aortic aneurysm with diameter of more than 4cm, Thoracic aortic aneurysm with diameter of more than 5cm, Aortic dissection, Cerebral aneurysm >=5mm b. Impared cardiac function: Transthoracic US: LVEF<40% or E/E'>15 or BNP>200 pg/mL c. hypertensive intracranial bleeding without confirmation of hemostasis (should be confirmed by CT for cerebral bleeding within 180 days) 6.Cushing syndrome or paraganglioma 7. Pregnancy or possibility of pregnancy 8. Hystory of iodine allergy 9. Participants of other clinical trial 10. Difficulty in cessation of the drugs which are prohibited in this trial 11. Patients who are judged as in adequate for this trial by the investigators.
Target sample size	10

Research contact person
Name of lead principal investigator	Kei Takase
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
TEL	022-717-7312
Email	ktakase@rad.med.tohoku.ac.jp

Public contact
Name of contact person	Kei Takase
Organization	Tohoku University Hospital
Division name	Department of Diagnostic Radiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL	022-717-7312
Homepage URL
Email	ktakase@rad.med.tohoku.ac.jp

Sponsor
Institute	Department of Diagnostic Radiology,Tohoku University Hospital
Institute
Department

Funding Source
Organization	Ministry of Health, Labor,and Welfare of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	OLYMPUS MEDICAL SYSTEMS CORP.(only device)
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 11 Month 29 Day
Anticipated trial start date	2014 Year 01 Month 22 Day
Last follow-up date	2014 Year 11 Month 10 Day
Date of closure to data entry	2015 Year 01 Month 19 Day
Date trial data considered complete	2015 Year 02 Month 23 Day
Date analysis concluded	2016 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 01 Month 08 Day
Last modified on	2017 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014141