Adrenal Tumors
Conditions
Keywords
adrenal gland
Brief summary
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.
Detailed description
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.
Interventions
PROCEDURERadiofrequency ablation
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.
Sponsors
Mie University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unresectable adrenal tumor which will be treated by radiofrequency (RF)ablation * Blood pressure is 140mmHg or less before RF ablation * Age of 20-years or more * Performance status of 0 or 1 * Agreement from the patient
Exclusion criteria
* Platelet count of 50,000/mm\^3 or International normalized ratio (INR)\>1.5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Catecholamine | One day | — |
| Serum Cathecholamine Levels | around one year | — |
| Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation | 1 week | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Increase in Cortisol | 1 day |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adrenal Radiofrequency Ablation Patients who received adrenal radiofrequency (RF) ablation. | 9 |
| Abdominal Radiofrequency Ablation Other Than Adrenal Gland Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Abdominal Radiofrequency Ablation Other Than Adrenal Gland | Adrenal Radiofrequency Ablation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 1 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 8 Participants | 11 Participants |
| Age, Continuous | 71 years STANDARD_DEVIATION 12 | 58 years STANDARD_DEVIATION 13 | 65 years STANDARD_DEVIATION 14 |
| Region of Enrollment Japan | 9 participants | 9 participants | 18 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Increase in Catecholamine
Time frame: One day
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.
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Adrenal Radiofrequency Ablation | Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation | 6 participants |
| Abdominal Radiofrequency Ablation Other Than Adrenal Gland | Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation | 1 participants |
p-value: <0.05Chi-squared, Corrected
Primary
Serum Cathecholamine Levels
Time frame: around one year
Secondary
Increase in Cortisol
Time frame: 1 day