The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
Status:
Recruiting
Trial end date:
2024-10-31
Target enrollment:
Participant gender:
Summary
Pheochromocytoma and paraganglioma (PPGL) are rare neuroendocrine tumors originating from
catecholamine producing chromaffin cells in the adrenal medulla and extra-adrenal
paraganglia. The overall age-standardized incidence rate is 0.18 per 100,000 person-years in
Korea.
The definitive treatment of PPGL is surgical excision of tumor. However, surgery is
associated with a high risk of perioperative hemodynamic instability (HI). To avoid
perioperative HI in patients diagnosed with PPGL, preoperative management including routine
use of alpha blockade and volume expansion has been advocated by several guidelines.
While unstable hypertension and tachycardia should be controlled in patients with PPGL, there
is controversial that all patients diagnosed with PPGL should undergo preoperative
pharmacological treatment, especially alpha blockade. The most important risk of preoperative
alpha blockade use is perioperative hypotension.
A recent study reported that patients diagnosed with PPGL postoperatively may have no further
higher risk of intraoperative hypertension than those diagnosed preoperatively despite
insufficient preoperatively management of PPGL.
Therefore, it is a very important to study the relationship between HI and preoperative alpha
blockade in normotensive patients diagnosed with PPGL. The aim this study is to analyze the
effect and safety of omitting preoperative alpha-adrenergic blockade for normotensive
pheochromocytoma through a prospective randomized controlled trial. The patients is divided
into two groups. The patients in control group take a phenoxybenzamine at least 2 to 5 weeks
before surgery. The patients in case group do not take a phenoxybenzamine.
Primary outcome is to evaluate the percentage of time during surgery with systolic blood
pressure more than 160mmHg or average blood pressure less than 60mmHg. And secondary outcomes
are to evaluate hemodynamic instability in preoperative ward and postoperative ward.