Neoplasms

All Conditions

Rare Diseases

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antihypertensive Agents

Vasodilator Agents

Adrenergic Agents

Phenoxybenzamine

Adrenergic alpha-Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

Phenoxybenzamine, an alpha receptor blocker, is taken at least 2 to 5 weeks before surgery

Phenoxybenzamine, an alpha receptor blocker, is not taken before surgery

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.

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

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

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.

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.

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.

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

Percentage of time during the surgery with systolic blood pressure \> 160mmHg or average blood pressure \< 60mmHg

1. Percentage of the surgery time greater than 100 times per pulse minute
2. Average systolic/diastolic blood pressure in millimeters of mercury and pulse in beats each minutes during surgery
3. Types and amount of antihypertensive drugs in mg per day during surgery
4. Types and amount of vasopressor drugs in mg per day during surgery

1. The number of times systolic blood pressure more than 130 mmHg and diastolic blood pressure more than 80mmHg in the preoperative ward
2. The number of times of pulse rate per minute more than 80 times in the preoperative ward

1. The number of times of average blood pressure less than 60mmHg in postoperative ward
2. Average blood pressure in postoperative ward
3. Types and amount of antihypertensive drugs in mg per day after surgery
4. Types and amount of vasopressor drugs in mg per day after surgery

Seoul National University Hospital

Associate Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Nutritional and Metabolic Diseases

Kidney Diseases

Adenoma

Kidney Failure, Chronic

Hyperplasia

Hyperaldosteronism

Adrenal Hyperplasia, Congenital

Adrenogenital Syndrome

Hypokalemia

Potassium Deficiency

Syndrome

Renal Insufficiency, Chronic

Renal Insufficiency

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Adrenocortical Hyperfunction

Adrenal Gland Diseases

Endocrine System Diseases

Disorders of Sex Development

Congenital Abnormalities

Urogenital Abnormalities

Genetic Diseases, Inborn

Metabolism, Inborn Errors

Steroid Metabolism, Inborn Errors

Metabolic Diseases

Gonadal Disorders

Chronic Disease

Disease Attributes

Water-Electrolyte Imbalance

Chronic Graft Versus Host Disease

Congenital Adrenal Hyperplasia

21-hydroxylase Deficiency

Hyperadrenalism

Channel Blockers

Diuretics

Sodium Channel Blockers

Diuretics, Potassium Sparing

Mineralocorticoid Receptor Antagonists

Mineralocorticoids

Patients treated with mineralocorticoid antagonists or potassium sparing diuretics for primary aldosteronism

Unilateral adrenalectomy in patients with unilateral disease

Troy Puar, MRCP

Troy Puar

Majority of patients with hypertension have primary hypertension (without an underlying cause). Primary aldosteronism (PA) is the most common cause of secondary hypertension, and can be found in 5-10% of patients locally. PA is caused by excessive release of a hormone (aldosterone) from the adrenal glands, which can be unilateral (one gland) or bilateral (both glands).

It has been shown that excess aldosterone has other harmful effects in addition to hypertension, such as directly affecting the heart, blood vessels, kidneys, leading to increased cardiovascular morbidity and mortality. This is supported by studies showing reversal of these effects after treatment for PA.

The investigators aim to assess the long-term cardiovascular, and renal outcomes of patients with PA, compared to patients with essential hypertension.

Outcome of Patients With Primary Aldosteronism

Long-term Outcomes in Patients With Primary Aldosteronism After Treatment

incidence of new cardiovascular events including acute myocardial infarction, revascularisation percutaneously, coronary artery bypass graft, stroke, admission for congestive cardiac failure, atrial fibrillation

incidence of worsening chronic kidney disease, decline of glomerular filtration rate by 15ml/min from at least 60m/min

rate of decline of glomerular filtration rate

Identify variables that are more common in patients with unilateral disease

Identify variables that are more common in patients with positive blood pressure response

Singapore General Hospital

Changi General Hospital

Adrenal Gland Neoplasms

Endocrine Gland Neoplasms

Adrenal Cancer

Vasoconstrictor Agents

Respiratory System Agents

Epinephrine

Racepinephrine

Epinephryl borate

Operations are done with an high definition 3D laparoscopic system (Olympus, Tokyo, Japan); all personnel wear polarized glasses to achieve stereoscopic imaging in the operating room. Dissection is realized using a hybrid energy system (Thunderbeat, Olympus Europe Se \& Co, Hamburg, Germany).

José Ignacio Rodríguez-Hermosa, MD, PhD

The main drawbacks of conventional 2D laparoscopy are limited depth perception and loss of spatial orientation. High-quality 3D laparoscopy systems might improve surgical outcomes for adrenalectomy.

Over recent decades, technological advances such as improved video imaging (high-definition cameras), better instrumentation for dissection and hemostasis, articulating staplers, and optimized operating room lighting have added safety, efficacy, and precision to minimally invasive procedures. However, until recently, laparoscopy required surgeons to operate in a three-dimensional (3D) space with only two-dimensional (2D) images to guide their movements, resulting in a lack of depth perception and loss of spatial orientation that increased the risk of errors, fatigue, operative time, and operating room stress and made the technique difficult to learn.

High-quality 3D laparoscopy was developed as an alternative to conventional 2D laparoscopy. Several clinical trials and observational studies have compared surgical outcomes between 2D and 3D laparoscopic systems; however, few clinical studies have examined the usefulness of 3D laparoscopy systems for adrenalectomies.

3D Laparoscopic Adrenalectomies for Adrenal Tumors

Three-dimensional Laparoscopic Adrenalectomies for Benign and Malignant Adrenal Tumors

Rate of medical and surgical complications within 30 days after surgery using the Dindo-Clavien classification, described as:

Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.

Total length of hospital stay will be recorded in days beginning at admission for surgery until discharge (number of days) .

Use of abdominal drainage intraoperatively (Yes vs No).

ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes

Adrenal mass \<6 cm, Adrenal mass ≥6 cm

Incidentaloma, Aldosteronoma, Pheochromocytoma, Cushing's Adenoma and malignant adrenal tumors (primary or metastasis)

Conversion (Yes vs No), operative time (min), bleeding (ml), Clavien-Dindo Classification

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

MD, PhD

Carcinoma

Neoplasm Metastasis

Cushing Syndrome

Adrenocortical Adenoma

Adrenocortical Carcinoma

Adrenal Cortex Neoplasms

Adrenal Cortex Diseases

Adenocarcinoma

Cushing's Syndrome

Adenoma of the Adrenal Gland

MUDr. Igor Hartmann Ph.D.

Natalia Wiesner

Igor Hartmqnn, MD, PhD

Natalia Wiesner, MD

Igor Hartmann, MD, PhD

The goal of this multicenter, observational, analytic, randomized clinical trial is to analyze the laparoscopic and robot-assisted method in the surgical treatment of patients with adrenal diseases. The main question it aims to answer are:

1. to find the superiority of one the the surgical method mentioned above
2. to compare the quality of life in patients with adrenal mass before surgery and after laparoscopic or robotic-assisted adrenalectomy.

Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy

Possibilities of Surgical Treatment of Adrenal Diseases: Comparison of Laparoscopic and Robotic-assisted Adrenalectomy-a Prospective Study

Initial examination by a urologist and indication for the surgery.

Sampling of biological material: Hemoglobin g/l

Measuring the blood loss in milliliters (ml).

Record the need for conversion to open surgery.

The consumption of special surgical instruments.

Perioperatively, the length of stay in the ICU in days.

Perioperatively, total hospitalization time in days

Perioperatively, blood loss from the drain in mililiters (ml).

Perioperatively, time to remove the abdominal drain in days.

Perioperatively, need for blood substitutes.

Perioperatively, number of forced surgical revisions.

Perioperatively, consumption of analgesics during the hospitalization.

First postoperative visit (14th to 20th postoperative day), sampling of biological material: Hemoglobin g/l

First postoperative visit (14th to 20th postoperative day)- an analysis of perioperative and early postoperative complications according to the Dindo Clavien classification

First postoperative visit (14th to 20th postoperative day)- necessary hospitalizations and operative revisions.

Second postoperative visit (85th to 100th postoperative day)- an analysis of late postoperative complications according to the Dindo Clavien classification.

Second postoperative visit (85th to 100th postoperative day)- necessary hospitalizations and operative revisions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma	NCT05702944	Pheochromocytom... Paraganglioma Adrenalectomy; ... Adrenergics Cau...	Phenoxybenzamin...	19 Years - 70 Years	Seoul National University Hospital
Outcome of Patients With Primary Aldosteronism	NCT04428827	Primary Aldoste... Primary Aldoste... Primary Aldoste... Adrenalectomy; ... Mineralocortico... Mineralocortico... Cardiovascular ... Chronic Renal D... Hypokalemia	Unilateral adre...	14 Years - 100 Years	Changi General Hospital
3D Laparoscopic Adrenalectomies for Adrenal Tumors	NCT04905706	Adrenal Tumor Adrenalectomy; ...		18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy	NCT06050057	Adrenal Tumor Adrenal Disease Adrenal Mass Adrenalectomy; ... Adrenal Hyperpl... Adrenal Gland M... Adrenal Cortex ... Pheochromocytom... Cushing Syndrom... Conn Adenoma Adrenocortical ... Adrenocortical ... Adrenocortical ...		18 Years -	University Hospital Olomouc
3D Laparoscopic Adrenalectomies for Adrenal Tumors	NCT04905706	Adrenal Tumor Adrenalectomy; ...		18 Years -	Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
The Effect and Safety of Omitting Preoperative Alpha-adrenergic Blockade for Normotensive Pheochromocytoma	NCT05702944	Pheochromocytom... Paraganglioma Adrenalectomy; ... Adrenergics Cau...	Phenoxybenzamin...	19 Years - 70 Years	Seoul National University Hospital

Spots Global Cancer Trial Database for adrenalectomy; status