Adrenal TumorsPhase 2/3NCT00997594
Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
A Phase 2/3 study testing Radiofrequency ablation in people with Adrenal Tumors, run by Mie University at 2 sites in Japan.
Trial summary
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Adrenal Tumors
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesJapan
- Study dates
- Oct 2009to Oct 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Platelet count of 50,000/mm^3 or International normalized ratio (INR)>1.5
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Mie University Hospital
Tsu, Mie-ken, 514-8507
Mie University
Tsu, Mie-ken, 514-8507
About this study
The purpose of this study is to evaluate changes in adrenal hormones during adrenal radiofrequency (RF) ablation.
Read the 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.
- Conditions
- Adrenal Tumors
- Being tested
- Radiofrequency ablation
- Keywords
- adrenal gland
- Medical subject headings
- Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Adrenal radiofrquency (RF) ablation | Active comparator | Patients who wll receive adrenal RF ablation. Receives: Procedure: Radiofrequency ablation |
| Abdominal RF ablation other than adrenal gland | Active comparator | Patients who will receive abdominal radiofrequency ablation other than adrenal gland. Receives: Procedure: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Catecholamine
Measured: One day
Serum Cathecholamine Levels
Measured: 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.
Measured: 1 week
Secondary outcomes (1)
Increase in Cortisol
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adrenal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichiro Yamakado, Mie University
- Investigators
- Koichiro Yamakado, MD, Study chair, Mie University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997594
- Sponsor's protocol ID
- 274
- Other IDs
- No secondary IDs
- Status last verified
- Apr 2015
- First submitted
- 16 Oct 2009
- Last updated
- 28 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Adrenal Hormones During Adrenal Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT00997594
- Acronym / sponsor ID
- 274
- Conditions
- Adrenal Tumors
- Keywords
- adrenal gland
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mie UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Posted 23 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adrenal radiofrquency (RF) ablation | Active comparator | Procedure: Radiofrequency ablationPatients who wll receive adrenal RF ablation. |
| Abdominal RF ablation other than adrenal gland | Active comparator | Procedure: Radiofrequency ablationPatients who will receive abdominal radiofrequency ablation other than adrenal gland. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Platelet count of 50,000/mm^3 or International normalized ratio (INR)>1.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRadiofrequency (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. | Procedure or surgery | Abdominal RF ablation other than adrenal gland, Adrenal radiofrquency (RF) ablation |
Primary outcome
Increase in Catecholamine
Time frame: One day
Serum Cathecholamine Levels
Time frame: around one year
Number of Participants With Hypertension During Adrenal or Non-adrenal Radiofrequency Ablation
Time frame: 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.
1 secondary outcome
Increase in Cortisol
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichiro Yamakado, MD study chair
Mie University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiofrequency ablation in people with Adrenal Tumors, run by Mie University at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Catecholamine (time frame: One day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2015.