Pheochromocytoma Clinical Trial
Official title:
A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | October 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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Kim JH, Lee HC, Kim SJ, Lee KE, Jung KC. Characteristics of Intraoperative Hemodynamic Instability in Postoperatively Diagnosed Pheochromocytoma and Sympathetic Paraganglioma Patients. Front Endocrinol (Lausanne). 2022 Feb 24;13:816833. doi: 10.3389/fendo.2022.816833. eCollection 2022. — View Citation
Kopetschke R, Slisko M, Kilisli A, Tuschy U, Wallaschofski H, Fassnacht M, Ventz M, Beuschlein F, Reincke M, Reisch N, Quinkler M. Frequent incidental discovery of phaeochromocytoma: data from a German cohort of 201 phaeochromocytoma. Eur J Endocrinol. 2009 Aug;161(2):355-61. doi: 10.1530/EJE-09-0384. Epub 2009 Jun 4. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect and safety of omitting preoperative alpha blockade during surgery | Percentage of time during the surgery with systolic blood pressure > 160mmHg or average blood pressure < 60mmHg | during surgery | |
Secondary | The effect and safety of omitting preoperative alpha blockade during surgery | Percentage of the surgery time greater than 100 times per pulse minute
Average systolic/diastolic blood pressure in millimeters of mercury and pulse in beats each minutes during surgery Types and amount of antihypertensive drugs in mg per day during surgery Types and amount of vasopressor drugs in mg per day during surgery |
during surgery | |
Secondary | The effect and safety of omitting preoperative alpha blockade before surgery | The number of times systolic blood pressure more than 130 mmHg and diastolic blood pressure more than 80mmHg in the preoperative ward
The number of times of pulse rate per minute more than 80 times in the preoperative ward |
3 days, 2 days, 1 day before surgery | |
Secondary | The effect and safety of omitting preoperative alpha blockade after surgery | The number of times of average blood pressure less than 60mmHg in postoperative ward
Average blood pressure in postoperative ward Types and amount of antihypertensive drugs in mg per day after surgery Types and amount of vasopressor drugs in mg per day after surgery |
1 day, 2 day, 2 weeks, 3 months after surgery |
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