UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015865 |
|---|---|
| Receipt number | R000018458 |
| Scientific Title | confirmatory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial) |
| Date of disclosure of the study information | 2014/12/08 |
| Last modified on | 2017/06/07 17:26:26 |
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Basic information
Public title
confirmatory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Acronym
confirmatory trial of radiofrequency ablation therapy for primary aldosteronism patients
Scientific Title
confirmatory trial to evaluate safety and efficacy of minimally invasive radiofrequency ablation therapy for primary aldosteronism patients (investigator-initiated clinical trial)
Scientific Title:Acronym
confirmatory 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
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
aldosterone normalization rate based on serum aldosterone consentration and alrosterone/renin ratio 7 days after ablation therapy
Key secondary outcomes
1. Clinical laboratory test
serum aldosterone, renin activity, Na,K, urine Na,K, ARR, TTKG, osmotic pressure and pottasium level, eGFR
2. Antihypertensive medication
Dose at screening and 3,7,28,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
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Takase |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi 980-8574 Japan
TEL
0227177312
ktakase@rad.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Takase |
Organization
Tohoku University Hospital
Division name
Department of Diagnostic Radiology
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8574, Japan
TEL
0227177312
Homepage URL
ktakase@rad.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology,Tohoku University Hospital
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 | 12 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 16 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018458
