RecruitingPhase 4NCT05702944

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

A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma

Sponsor

Seoul National University Hospital

Enrollment

24 participants

Start Date

Jan 18, 2023

Study Type

INTERVENTIONAL

Conditions

Paraganglioma Pheochromocytoma Adrenalectomy; Status Adrenergics Causing Adverse Effects in Therapeutic Use

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

Min Age: 19 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether patients with a type of adrenal tumor called a normotensive pheochromocytoma — meaning one that does not cause high blood pressure — can safely have their adrenal gland removed without the standard pre-surgery medication (alpha-adrenergic blockade) that is typically given to prevent dangerous blood pressure swings during the operation. You may be eligible if: - You are between 19 and 70 years old - You have consented to participate in the study - You have a normotensive pheochromocytoma or paraganglioma with mildly elevated blood markers (less than 5 times the upper limit of serum metanephrine) - You are scheduled for unilateral (one-sided) total adrenal gland removal You may NOT be eligible if: - You are younger than 18 or older than 70 - You are pregnant - You have a pheochromocytoma in both adrenal glands - Your tumor is suspected to be malignant or has spread to other parts of the body - You require pre-operative intensive care due to unstable blood pressure - You have high blood pressure or are currently taking blood pressure medication - You have a history of coronary artery disease - You have a history of arrhythmia (such as atrial fibrillation or paroxysmal SVT) - You have a history of stroke, cerebral aneurysm, or brain hemorrhage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPhenoxybenzamine

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.