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| ID | Type | Description | Link |
|---|---|---|---|
| No secondary IDs |
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The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.
Adrenal radiofrequency (RF) ablation has been increasingly used for the treatment of unresectable adrenal tumors. But one of the major complication is a increase in blood pressure. Hormonal release during RF ablation is considered the cause of hypertension. But there has been no evidence that adrenal hormones affects changes in blood pressure. In this prospective study, we evaluate the changes in adrenal hormones during RF ablation and clarify the cause of hypertensive crisis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adrenal radiofrquency (RF) ablation | Active Comparator | Patients who wll receive adrenal RF ablation. |
|
| Abdominal RF ablation other than adrenal gland | Active Comparator | Patients who will receive abdominal radiofrequency ablation other than adrenal gland. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Procedure | Radiofrequency (RF) ablation was done after RF electrodes were placed in the adrenal tumor in the adrenal RF ablation group. RF ablation was done after RF electrodes were placed in the targeted abdominal tumors other than adrenal gland in the abdominal RF ablation other than adrenal gland group. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Catecholamine | One day | |
| Serum Cathecholamine Levels | around one year | |
| Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation | Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Increase in Cortisol | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Koichiro Yamakado, MD | Mie University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mie University Hospital | Tsu | Mie-ken | 514-8507 | Japan | ||
| Mie University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adrenal Radiofrequency Ablation | Patients who received adrenal radiofrequency (RF) ablation. |
| FG001 | Abdominal Radiofrequency Ablation Other Than Adrenal Gland | Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adrenal Radiofrequency Ablation | Patients who received adrenal radiofrequency (RF) ablation. |
| BG001 | Abdominal Radiofrequency Ablation Other Than Adrenal Gland | Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Increase in Catecholamine | Not Posted | One day | |||||||||||||
| Secondary | Increase in Cortisol | Not Posted | 1 day | |||||||||||||
1 week to 1 year (mean, 215 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adrenal Radiofrequency Ablation | Patients who received adrenal radiofrequency (RF) ablation. |
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Small patient series is one of limitations of this study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Koichiro Yamakado | Mie University | +81-59-231-5029 | 5630 | yama@clin.medic.mie-u.ac.jp |
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| ID | Term |
|---|---|
| D000310 | Adrenal Gland Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D000307 | Adrenal Gland Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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|
| Tsu |
| Mie-ken |
| 514-8507 |
| Japan |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum Cathecholamine Levels |
| Not Posted |
| Oct 2015 |
| Mean |
| around one year |
| Primary | Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation | Blood pressure was monitored during radiofrequency (RF) ablation. The frequency of hypertension (systolic blood pressure of more than 200 mmHg) was evaluated and compared between the adrenal and non-adrenal (RF ablation other than adrenal gland) RF ablation groups. | Posted | Number | participants | 1 week |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Abdominal Radiofrequency Ablation Other Than Adrenal Gland | Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney. | 0 | 9 | 0 | 9 |
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| D004700 |
| Endocrine System Diseases |