Actively Recruiting

Phase 4
Age: 19Years - 70Years
All Genders
ID05702944

Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma in a Randomized Controlled Trial

Led by Seoul National University Hospital · Updated on 2025-06-12

24

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Pheochromocytoma and paraganglioma (PPGL) are rare tumors that develop from cells producing catecholamines in the adrenal glands or nearby tissues. These tumors can cause symptoms like headache, palpitations, sweating, and high blood pressure, and may lead to serious heart and brain complications. Surgery to remove the tumor is the main treatment, but it carries a risk of unstable blood pressure during the operation. Current guidelines recommend preoperative management with alpha blockers to reduce this risk, but it is uncertain if all patients, especially those with normal blood pressure, need this treatment. This study compares two groups of patients with normotensive PPGL undergoing surgery. One group receives phenoxybenzamine, an alpha blocker, for 2 to 5 weeks before surgery with dose adjustments based on blood pressure. The other group does not receive this medication before surgery. The study aims to analyze whether skipping the alpha blocker affects blood pressure stability during surgery and assess the safety of this approach. Participants will be monitored for blood pressure changes during surgery as the main measurement. Additional evaluations will track blood pressure stability before and after surgery in the hospital wards. The study will also observe any side effects or complications related to blood pressure management. The total participation duration includes the preoperative period, the surgery itself, and follow-ups up to three months after surgery to evaluate safety and effectiveness.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 19 to 70 years old
  • Patients who consented to the study
  • Patients undergoing unilateral total adrenalectomy due to normotensive pheochromocytoma or paraganglioma with serum metanephrine less than five times the upper limit
Not Eligible

You will not qualify if you...

  • Patients under 18 or over 70 years old
  • Pregnant women
  • Patients with bilateral pheochromocytoma
  • Patients suspected of malignant pheochromocytoma or distant metastasis
  • Patients requiring preoperative intensive care due to severe hemodynamic instability
  • Patients with hypertension (blood pressure consistently over 140/90 mmHg) or using antihypertensive medication
  • Patients with history of coronary artery disease
  • Patients with history of arrhythmia such as atrial fibrillation or supraventricular tachycardia
  • Patients with history of cerebrovascular disease including cerebral aneurysm, infarction, or hemorrhage
  • Patients deemed unsuitable by the clinical trial investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 to 5 weeks

Participants are assigned to either take phenoxybenzamine for 2 to 5 weeks before surgery or to omit preoperative alpha blockade, followed by surgery.

Multiple visits during the 2 to 5 weeks before surgery

Surgery and Immediate Post-operative Care

Duration - Until discharge after surgery

Participants undergo unilateral total adrenalectomy surgery followed by immediate post-operative monitoring.

Hospital stays with continuous monitoring during surgery and immediate post-operative period

Post-operative Follow-up

Duration - Up to 3 months

Participants are monitored for safety and hemodynamic stability after surgery.

Visits at 1 day, 2 days, 2 weeks, and 3 months after surgery

Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

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Research Team

S

Su-Jin Kim, M.D., Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

The North American Neuroendocrine Tumor Society consensus guideline for the diagnosis and management of neuroendocrine tumors: pheochromocytoma, paraganglioma, and medullary thyroid cancer.

Herbert Chen, Rebecca S Sippel, M Sue O'Dorisio...

https://pubmed.ncbi.nlm.nih.gov/20664475

Normotensive incidentally discovered pheochromocytomas display specific biochemical, cellular, and molecular characteristics.

Magalie Haissaguerre, Maïté Courel, Philippe Caron...

https://pubmed.ncbi.nlm.nih.gov/24001749