PheochromocytomaPhase 4NCT05702944
The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
A Phase 4 study testing Phenoxybenzamine in people with Pheochromocytoma and Paraganglioma, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Pheochromocytoma, Paraganglioma, Adrenalectomy; Status
- What is being tested?
- Phenoxybenzamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jan 2023to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Su-Jin Kim, M.D., Ph.D., +82-2-2072-7208, su.jin.kim.md@gmail.com
About this study
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.
Read more
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.
Read the detailed description
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 classical clinical presentations that occur due to the release of catecholamine include headache, palpitation, sweating and hypertension. Excessive catecholamine release from PPGLs can induce life-threatening complication such as myocardial infarction, heart failure, cardiomyopathy, shock, arrhythmias, and stroke. 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. The patients with prolonged preoperative alpha blockade may require intravenous fluid and vasopressors. In the recent randomized controlled trial comparing the efficacy of two different alpha blockade, 80-92% of patients reported mild to moderate side effect on alpha blockade.
The proportion of patients who are incidentally diagnosed with PPGLs are increasing. According to the recent study, the European registry for endocrine tumors revealed that incidentaloma were present in 43.4% (239/551 patients) of pheochromocytoma patients, 11.8% (65/551 patients) of patients were diagnosed as pheochromocytoma after adrenalectomy. Patients who were diagnosed with PPGL postoperatively did not undergo proper preoperative management to prevent perioperative HI. Most of them were normotensive patients and there were no specific findings on laboratory or radiologic examination suggesting PPGLs. In addition, 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 department of endocrine surgery in Seoul National University Hospital intends 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. If blood pressure is more than 130/80mmHg in the sitting position, the patient will take a more amount of phenoxybenzamine. If blood pressure is less than 90mmHg in the standing position, the patients will take a less amount of phenoxybenzamine. In the case group, there is no drug to be taken.
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.
- Conditions
- Pheochromocytoma, Paraganglioma, Adrenalectomy; Status, Adrenergics Causing Adverse Effects in Therapeutic Use
- Being tested
- Phenoxybenzamine
- Medical subject headings
- Pheochromocytoma, Paraganglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenoxybenzamineDrug
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 group | Role | What they receive |
|---|---|---|
| Phenoxybenzamine before surgery | Sham comparator | Phenoxybenzamine, an alpha receptor blocker, is taken at least 2 to 5 weeks before surgery Receives: Drug: Phenoxybenzamine |
| No phenoxybenzamine before surgery | Active comparator | Phenoxybenzamine, an alpha receptor blocker, is not taken before surgery Receives: Drug: Phenoxybenzamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during surgery
Secondary outcomes (3)
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
Measured: during surgery
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
Measured: 3 days, 2 days, 1 day before surgery
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
Measured: 1 day, 2 day, 2 weeks, 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start18 Jan 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in control 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 the case group, there is no drug to be taken.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Su-jin Kim, Seoul National University Hospital
- Investigators
- Su-Jin Kim, M.D., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702944
- Sponsor's protocol ID
- 2209-044-1357
- Status last verified
- Jun 2025
- First submitted
- 10 Nov 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stenstrom G, Svardsudd K. Pheochromocytoma in Sweden 1958-1981. An analysis of the National Cancer Registry Data. Acta Med Scand. 1986;220(3):225-32.
PubMed 3776697Sheps SG, Jiang NS, Klee GG. Diagnostic evaluation of pheochromocytoma. Endocrinol Metab Clin North Am. 1988 Jun;17(2):397-414.
PubMed 3042392Samaan NA, Hickey RC, Shutts PE. Diagnosis, localization, and management of pheochromocytoma. Pitfalls and follow-up in 41 patients. Cancer. 1988 Dec 1;62(11):2451-60. doi: 10.1002/1097-0142(19881201)62:113.0.co;2-q.
PubMed 3179962Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.
PubMed 24893135Lenders JW, Eisenhofer G, Mannelli M, Pacak K. Phaeochromocytoma. Lancet. 2005 Aug 20-26;366(9486):665-75. doi: 10.1016/S0140-6736(05)67139-5.
PubMed 16112304Pacak K. Preoperative management of the pheochromocytoma patient. J Clin Endocrinol Metab. 2007 Nov;92(11):4069-79. doi: 10.1210/jc.2007-1720.
PubMed 17989126Chen H, Sippel RS, O'Dorisio MS, Vinik AI, Lloyd RV, Pacak K; North American Neuroendocrine Tumor Society (NANETS). The North American Neuroendocrine Tumor Society consensus guideline for the diagnosis and management of neuroendocrine tumors: pheochromocytoma, paraganglioma, and medullary thyroid cancer. Pancreas. 2010 Aug;39(6):775-83. doi: 10.1097/MPA.0b013e3181ebb4f0.
PubMed 20664475Haissaguerre M, Courel M, Caron P, Denost S, Dubessy C, Gosse P, Appavoupoulle V, Belleannee G, Jullie ML, Montero-Hadjadje M, Yon L, Corcuff JB, Fagour C, Mazerolles C, Wagner T, Nunes ML, Anouar Y, Tabarin A. Normotensive incidentally discovered pheochromocytomas display specific biochemical, cellular, and molecular characteristics. J Clin Endocrinol Metab. 2013 Nov;98(11):4346-54. doi: 10.1210/jc.2013-1844. Epub 2013 Sep 3.
PubMed 24001749Kopetschke 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.
PubMed 19497985Noshiro T, Shimizu K, Watanabe T, Akama H, Shibukawa S, Miura W, Ito S, Miura Y. Changes in clinical features and long-term prognosis in patients with pheochromocytoma. Am J Hypertens. 2000 Jan;13(1 Pt 1):35-43. doi: 10.1016/s0895-7061(99)00139-9.
PubMed 10678269Bruynzeel H, Feelders RA, Groenland TH, van den Meiracker AH, van Eijck CH, Lange JF, de Herder WW, Kazemier G. Risk Factors for Hemodynamic Instability during Surgery for Pheochromocytoma. J Clin Endocrinol Metab. 2010 Feb;95(2):678-85. doi: 10.1210/jc.2009-1051. Epub 2009 Dec 4.
PubMed 19965926Shao Y, Chen R, Shen ZJ, Teng Y, Huang P, Rui WB, Xie X, Zhou WL. Preoperative alpha blockade for normotensive pheochromocytoma: is it necessary? J Hypertens. 2011 Dec;29(12):2429-32. doi: 10.1097/HJH.0b013e32834d24d9.
PubMed 22025238Lafont M, Fagour C, Haissaguerre M, Darancette G, Wagner T, Corcuff JB, Tabarin A. Per-operative hemodynamic instability in normotensive patients with incidentally discovered pheochromocytomas. J Clin Endocrinol Metab. 2015 Feb;100(2):417-21. doi: 10.1210/jc.2014-2998. Epub 2014 Nov 18.
PubMed 25405501Buitenwerf E, Osinga TE, Timmers HJLM, Lenders JWM, Feelders RA, Eekhoff EMW, Haak HR, Corssmit EPM, Bisschop PHLT, Valk GD, Veldman RG, Dullaart RPF, Links TP, Voogd MF, Wietasch GJKG, Kerstens MN. Efficacy of alpha-Blockers on Hemodynamic Control during Pheochromocytoma Resection: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2020 Jul 1;105(7):2381-91. doi: 10.1210/clinem/dgz188.
PubMed 31714582Kim 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.
PubMed 35282440
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for Randomized Controlled Trial on the Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma
- ClinicalTrials.gov ID
- NCT05702944
- Acronym / sponsor ID
- 2209-044-1357
- Conditions
- Pheochromocytoma, Paraganglioma, Adrenalectomy; Status, Adrenergics Causing Adverse Effects in Therapeutic Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 classical clinical presentations that occur due to the release of catecholamine include headache, palpitation, sweating and hypertension. Excessive catecholamine release from PPGLs can induce life-threatening complication such as myocardial infarction, heart failure, cardiomyopathy, shock, arrhythmias, and stroke. 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. The patients with prolonged preoperative alpha blockade may require intravenous fluid and vasopressors. In the recent randomized controlled trial comparing the efficacy of two different alpha blockade, 80-92% of patients reported mild to moderate side effect on alpha blockade.
The proportion of patients who are incidentally diagnosed with PPGLs are increasing. According to the recent study, the European registry for endocrine tumors revealed that incidentaloma were present in 43.4% (239/551 patients) of pheochromocytoma patients, 11.8% (65/551 patients) of patients were diagnosed as pheochromocytoma after adrenalectomy. Patients who were diagnosed with PPGL postoperatively did not undergo proper preoperative management to prevent perioperative HI. Most of them were normotensive patients and there were no specific findings on laboratory or radiologic examination suggesting PPGLs. In addition, 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 department of endocrine surgery in Seoul National University Hospital intends 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. If blood pressure is more than 130/80mmHg in the sitting position, the patient will take a more amount of phenoxybenzamine. If blood pressure is less than 90mmHg in the standing position, the patients will take a less amount of phenoxybenzamine. In the case group, there is no drug to be taken.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in control 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 the case group, there is no drug to be taken.
| Arm | Type | Receives |
|---|---|---|
| Phenoxybenzamine before surgery | Sham comparator | Drug: PhenoxybenzaminePhenoxybenzamine, an alpha receptor blocker, is taken at least 2 to 5 weeks before surgery |
| No phenoxybenzamine before surgery | Active comparator | Drug: PhenoxybenzaminePhenoxybenzamine, an alpha receptor blocker, is not taken before surgery |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenoxybenzaminePatients 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. | Drug | No phenoxybenzamine before surgery, Phenoxybenzamine before surgery |
Primary outcome
The effect and safety of omitting preoperative alpha blockade during surgery
Time frame: during surgery
Percentage of time during the surgery with systolic blood pressure > 160mmHg or average blood pressure < 60mmHg
3 secondary outcomes
The effect and safety of omitting preoperative alpha blockade during surgery
Time frame: during surgery
The effect and safety of omitting preoperative alpha blockade before surgery
Time frame: 3 days, 2 days, 1 day before surgery
The effect and safety of omitting preoperative alpha blockade after surgery
Time frame: 1 day, 2 day, 2 weeks, 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Background: PubMed 3776697Stenstrom G, Svardsudd K. Pheochromocytoma in Sweden 1958-1981. An analysis of the National Cancer Registry Data. Acta Med Scand. 1986;220(3):225-32.
- Background: PubMed 3042392Sheps SG, Jiang NS, Klee GG. Diagnostic evaluation of pheochromocytoma. Endocrinol Metab Clin North Am. 1988 Jun;17(2):397-414.
- Background: PubMed 3179962Samaan NA, Hickey RC, Shutts PE. Diagnosis, localization, and management of pheochromocytoma. Pitfalls and follow-up in 41 patients. Cancer. 1988 Dec 1;62(11):2451-60. doi: 10.1002/1097-0142(19881201)62:113.0.co;2-q.
- Background: PubMed 24893135Lenders JW, Duh QY, Eisenhofer G, Gimenez-Roqueplo AP, Grebe SK, Murad MH, Naruse M, Pacak K, Young WF Jr; Endocrine Society. Pheochromocytoma and paraganglioma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2014 Jun;99(6):1915-42. doi: 10.1210/jc.2014-1498.
- Background: PubMed 16112304Lenders JW, Eisenhofer G, Mannelli M, Pacak K. Phaeochromocytoma. Lancet. 2005 Aug 20-26;366(9486):665-75. doi: 10.1016/S0140-6736(05)67139-5.
- Background: PubMed 17989126Pacak K. Preoperative management of the pheochromocytoma patient. J Clin Endocrinol Metab. 2007 Nov;92(11):4069-79. doi: 10.1210/jc.2007-1720.
- Background: PubMed 20664475Chen H, Sippel RS, O'Dorisio MS, Vinik AI, Lloyd RV, Pacak K; North American Neuroendocrine Tumor Society (NANETS). The North American Neuroendocrine Tumor Society consensus guideline for the diagnosis and management of neuroendocrine tumors: pheochromocytoma, paraganglioma, and medullary thyroid cancer. Pancreas. 2010 Aug;39(6):775-83. doi: 10.1097/MPA.0b013e3181ebb4f0.
- Background: PubMed 24001749Haissaguerre M, Courel M, Caron P, Denost S, Dubessy C, Gosse P, Appavoupoulle V, Belleannee G, Jullie ML, Montero-Hadjadje M, Yon L, Corcuff JB, Fagour C, Mazerolles C, Wagner T, Nunes ML, Anouar Y, Tabarin A. Normotensive incidentally discovered pheochromocytomas display specific biochemical, cellular, and molecular characteristics. J Clin Endocrinol Metab. 2013 Nov;98(11):4346-54. doi: 10.1210/jc.2013-1844. Epub 2013 Sep 3.
- Background: PubMed 19497985Kopetschke 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.
- Background: PubMed 10678269Noshiro T, Shimizu K, Watanabe T, Akama H, Shibukawa S, Miura W, Ito S, Miura Y. Changes in clinical features and long-term prognosis in patients with pheochromocytoma. Am J Hypertens. 2000 Jan;13(1 Pt 1):35-43. doi: 10.1016/s0895-7061(99)00139-9.
- Background: PubMed 19965926Bruynzeel H, Feelders RA, Groenland TH, van den Meiracker AH, van Eijck CH, Lange JF, de Herder WW, Kazemier G. Risk Factors for Hemodynamic Instability during Surgery for Pheochromocytoma. J Clin Endocrinol Metab. 2010 Feb;95(2):678-85. doi: 10.1210/jc.2009-1051. Epub 2009 Dec 4.
- Background: PubMed 22025238Shao Y, Chen R, Shen ZJ, Teng Y, Huang P, Rui WB, Xie X, Zhou WL. Preoperative alpha blockade for normotensive pheochromocytoma: is it necessary? J Hypertens. 2011 Dec;29(12):2429-32. doi: 10.1097/HJH.0b013e32834d24d9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Su-Jin Kim, M.D., Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenoxybenzamine in people with Pheochromocytoma and Paraganglioma, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Su-Jin Kim, M.D., Ph.D. (+82-2-2072-7208, su.jin.kim.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect and safety of omitting preoperative alpha blockade during surgery (time frame: during surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05702944, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.