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

NCT05702944 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Phase 4

Started

2023-01-18

Last updated

2025-06-12

Condition(s) studied

PheochromocytomaParagangliomaAdrenalectomy; StatusAdrenergics Causing Adverse Effects in Therapeutic Use

Investigational drug(s) / intervention(s)

Phenoxybenzamine

Phenoxybenzamine: Patients in sham comparator group take a phenoxybenzamine at least 2 to 5 weeks before surgery. If blood pressure is more than 130/80 mmHg in the sitting position, the patient will take a more amount of phenoxybenzamine. If blood pressure is less than 90 mmHg in the standing position, the patient will take a less amount of phenoxybenzamine. In active comparator group, there is no drug to be taken.

Study 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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

The effect and safety of omitting preoperative alpha blockade during surgery — during surgery
Percentage of time during the surgery with systolic blood pressure \> 160mmHg or average blood pressure \< 60mmHg

Trial sites (1)

Facility	City	Region	Status
Seoul National University Hospital	Seoul	South Korea	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05702944 on ClinicalTrials.gov ↗ ← All trials in South Korea