NCT05702944 The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
| NCT ID | NCT05702944 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Pheochromocytoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2023-01-18 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 24 participants in total. It began in 2023-01-18 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Su-Jin Kim, M.D., Ph.D
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT05702944 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 70 Years, studying Pheochromocytoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05702944 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05702944 currently recruiting?
Yes, NCT05702944 is actively recruiting participants. Contact the research team at su.jin.kim.md@gmail.com for enrollment information.
Where is the NCT05702944 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05702944 clinical trial?
NCT05702944 is sponsored by Seoul National University Hospital. The principal investigator is Su-Jin Kim, M.D., Ph.D at Seoul National University Hospital. The trial plans to enroll 24 participants.