Preoperative Alpha Blockade for Pheochromocytoma
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/6/2018 |
| Start Date: | May 5, 2017 |
| End Date: | May 2024 |
| Contact: | Eric J Kuo, MD |
| Email: | ekuo@mednet.ucla.edu |
| Phone: | 310-206-0585 |
Randomized Controlled Trial of Preoperative Alpha Blockade for Pheochromocytoma
Pheochromocytoma is a rare, catecholamine (ex. adrenaline) secreting tumor that requires
preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby
reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a
non-selective alpha blocker that is significantly more expensive and is associated with
increased adverse effects in comparison with selective alpha blockers such as doxazosin.
Retrospective studies show minimal differences in hemodynamic instability and no differences
in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.
This study is a randomized controlled trial that will compare hemodynamic instability,
morbidity, mortality, cost, and quality of life between patients blocked with
phenoxybenzamine vs. doxazosin.
preoperative alpha blockade to minimize intraoperative hemodynamic instability, thereby
reducing intra- and postoperative morbidity and mortality. Phenoxybenzamine is a
non-selective alpha blocker that is significantly more expensive and is associated with
increased adverse effects in comparison with selective alpha blockers such as doxazosin.
Retrospective studies show minimal differences in hemodynamic instability and no differences
in postoperative morbidity and mortality between selective vs. non-selective alpha blockers.
This study is a randomized controlled trial that will compare hemodynamic instability,
morbidity, mortality, cost, and quality of life between patients blocked with
phenoxybenzamine vs. doxazosin.
Pheochromocytoma is a catecholamine (ex. adrenaline) secreting tumor for which the primary
treatment is surgical resection. Due to the hormones secreted by the tumor, alpha receptors
on peripheral blood vessels are activated, causing constriction of these blood vessels and
dangerously high blood pressure. During resection of the tumor, the source of excess hormone
secretion is abruptly removed, which can lead to life-threatening blood pressure fluctuations
during surgery.
Alpha blockers are a class of medication that blocks the alpha receptor on blood vessels.
Given preoperatively over a few weeks, these medications negate the effects of the excess
hormones secreted by the pheochromocytoma, reducing the frequency and severity of dangerous
blood pressure fluctuations intraoperatively and postoperatively. Preoperative alpha blockade
is therefore critical to safely perform surgery to resect pheochromocytoma.
Phenoxybenzamine, a non-selective alpha blocker, is the most common medication used to alpha
block patients prior to pheochromocytoma resection. However, due to increasing drug costs and
increased side effects in comparison with selective alpha blockers, there is a renewed
interest in studying alternatives to phenoxybenzamine.
Selective alpha blockers such as doxazosin are also commonly used to alpha block patients
prior to pheochromocytoma resection. Selective alpha blockers are significantly less
expensive and are associated with fewer side effects than phenoxybenzamine. Most
retrospective studies comparing phenoxybenzamine with selective alpha blockers show no
difference in intraoperative blood pressure fluctuations, morbidity, or mortality in
pheochromocytoma resection. However, no prospective, randomized controlled trials comparing
phenoxybenzamine to selective alpha blockers have been performed.
The purpose of our study is to analyze preoperative, intraoperative, and postoperative
outcomes in patients randomized to receive phenoxybenzamine (non-selective) or doxazosin
(selective) for alpha blockade prior to pheochromocytoma resection. Outcomes will include
postoperative morbidity and mortality, intraoperative hemodynamic instability, quality of
life, and cost.
treatment is surgical resection. Due to the hormones secreted by the tumor, alpha receptors
on peripheral blood vessels are activated, causing constriction of these blood vessels and
dangerously high blood pressure. During resection of the tumor, the source of excess hormone
secretion is abruptly removed, which can lead to life-threatening blood pressure fluctuations
during surgery.
Alpha blockers are a class of medication that blocks the alpha receptor on blood vessels.
Given preoperatively over a few weeks, these medications negate the effects of the excess
hormones secreted by the pheochromocytoma, reducing the frequency and severity of dangerous
blood pressure fluctuations intraoperatively and postoperatively. Preoperative alpha blockade
is therefore critical to safely perform surgery to resect pheochromocytoma.
Phenoxybenzamine, a non-selective alpha blocker, is the most common medication used to alpha
block patients prior to pheochromocytoma resection. However, due to increasing drug costs and
increased side effects in comparison with selective alpha blockers, there is a renewed
interest in studying alternatives to phenoxybenzamine.
Selective alpha blockers such as doxazosin are also commonly used to alpha block patients
prior to pheochromocytoma resection. Selective alpha blockers are significantly less
expensive and are associated with fewer side effects than phenoxybenzamine. Most
retrospective studies comparing phenoxybenzamine with selective alpha blockers show no
difference in intraoperative blood pressure fluctuations, morbidity, or mortality in
pheochromocytoma resection. However, no prospective, randomized controlled trials comparing
phenoxybenzamine to selective alpha blockers have been performed.
The purpose of our study is to analyze preoperative, intraoperative, and postoperative
outcomes in patients randomized to receive phenoxybenzamine (non-selective) or doxazosin
(selective) for alpha blockade prior to pheochromocytoma resection. Outcomes will include
postoperative morbidity and mortality, intraoperative hemodynamic instability, quality of
life, and cost.
Inclusion Criteria:
- Adults with pheochromocytoma / paraganglioma undergoing surgical resection
Exclusion Criteria:
- Children < 18 years
We found this trial at
1
site
Los Angeles, California 90095
310-825-4321
Principal Investigator: Masha J Livhits, MD
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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