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The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma

RecruitingPhase 4Ages 19 Years - 70 YearsAllSeoul National University Hospital
NCT05702944 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 bloc

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged 19 to 70 years old * Patients who consented to the study and obtained consent for the study * Patients undergoing unilateral total adrenalectomy due to normotensive pheochromocytoma/paraganglioma with less than five times of upper limits of serum metanephrine Exclusion Criteria: * Patients under 18 or over 70 years old * Pregnant women * Patients with bilateral pheochromocytoma * Patients suspected of malignant pheochromocytoma/paraganglioma or distant metastasis * Patients requiring preoperative intensive care unit due to severe hemodynamic instability * Patients with hypertension (the blood pressure measured more than two times is constantly greater than 140/90 mmHg) or already taking a antihypertensive medication * Patients with a history of coronary artery disease * Patients with a history of arrhythmia (atrial fibrillation, Paroxysmal supraventricular tachycardia) * Patients with a history of cerebrovascular disease (cerebral aneurysm, cerebral infarction, cerebral hemorrhage) * Patients judged unsuitable by the person in charge of the clinical trial
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What it tests

  • Phenoxybenzamine
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Where

1 site
Seoul National University Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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