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.

开始日期2023-01-18

申办/合作机构

Seoul National University Hospital

NCT01379898

/ Completed临床4期

Pheochromocytoma Randomised Study Comparing Adrenoreceptor Inhibiting Agents for Preoperative Treatment

* Rationale: The optimal preoperative medical management for patients with a pheochromocytoma is currently unknown. In particular, there is no agreement with respect to whether phenoxybenzamine or doxazosin is the optimal alfa-adrenoreceptor antagonist to be administered before surgical resection of a pheochromocytoma. We hypothesized that the competitive alfa1-antagonist doxazosin is superior to the non-competitive alfa1- and alfa2-antagonist phenoxybenzamine.
* Objective: comparing effects of preoperative treatment with either phenoxybenzamine or doxazosin on intraoperative hemodynamic control in patients undergoing surgical resection of a pheochromocytoma.
* Study design: Randomised controlled open-label trial.
* Study population: 18 - 55 yr old. Adult patients with a recently diagnosed benign pheochromocytoma.
* Intervention: Patients are randomised to receive oral treatment with either phenoxybenzamine or doxazosin preoperatively.
* Main study parameters/endpoints: The main study parameter is defined as the percentage of intraoperative time that blood pressure is outside the predefined target range after pretreatment with either phenoxybenzamine or doxazosin.
In this multicenter trial, we compare the effects of two commonly used drugs in patients being medically prepared for resection of a benign pheochromocytoma. Participants are not subjected to an experimental treatment of any kind, as we merely aim to describe in detail the perioperative course in general and, in particular, the intraoperative hemodynamic control in patients treated preoperatively with either phenoxybenzamine or doxazosin. A routine diagnostic work-up for pheochromocytoma will be performed in all participants. One extra blood sample (volume: 48,5 mL) is drawn before start of the study medication, and participants need to record their symptoms in a diary. In addition, patients who are pretreated in the outpatient clinic monitor their blood pressure and pulse rate at home with an automated device. Treatment with an alfa-adrenoreceptor antagonist is initiated at least 2 - 3 weeks prior to surgery. Patients who are admitted to the hospital for pretreatment with an alfa-adrenoreceptor antagonist have their blood pressure and pulse rate measured by the nursing staff. The final site visit is planned at 30 days after surgery, in line with current practice.

开始日期2011-12-01

申办/合作机构

University Medical Center Groningen

[+14]

CTRI/2011/09/002019

/ Recruiting临床4期IIT

Comparative study of pre-operative blockade using Phenoxybenzamine vs. Prazosin efficacy ( intra- and post-operative hemodynamic changes) and safety profile in Pheochromocytoma

开始日期2011-09-27

申办/合作机构

Sanjay Gandhi Post Graduate Institute of Medical Sciences

100 项与盐酸酚苄明相关的临床结果

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100 项与盐酸酚苄明相关的转化医学

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100 项与盐酸酚苄明相关的专利（医药）

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项与盐酸酚苄明相关的文献（医药）

2025-02-01·FOOD CHEMISTRY

Study on the foam properties of peanut oil body (POB)-based oil-in-water-in-oil (O/W/O) foamed emulsion gel: The key role played by the interface between the water phase and the outer oil phase

Article

作者: Li, Kangyu ; Shi, Zhangyu ; Meng, Zong

A novel POB-based O/W/O foamed emulsion gel was constructed. The mechanism by which POB strengthens the foamed emulsion gel was preliminarily explored by studying the microstructure and rheological properties, and the applications of POB in decoration and 3D printing were analyzed. The adsorption of POBs and their fragments might strengthen the interface between the water and internal oil phases, thereby increasing the yield stress of the system, which protected the O/W/O structure from being damaged during whipping, and formed a special foam structure where air-in-oil (A/O) structures and O/W/O structure coexist. Besides, adding POB promoted the overrun of the emulsion gel, and the maximum overrun rate was 68.6 %. Finally, POB-based O/W/O foamed emulsion gel exhibited good decoration and 3D printing performance and is expected to become a healthy and higher-quality foamed food in the future.

2024-12-16·Cureus Journal of Medical Science

Extra-adrenal Pheochromocytoma of the Urinary Bladder in an Adolescent Female Patient

Article

作者: Do, Pauline ; Davis, James W ; Bajaj, Kunal ; Edry, Gili ; Neibling, James

Pheochromocytoma is a catecholamine-secreting tumor that arises from the medullary chromaffin cells but can rarely be extra-adrenal in origin. We present a case of a 16-year-old female patient with uncontrolled hypertension, despite being on lisinopril and metoprolol, and associated left-sided chest pain, recurrent headaches, and an unintentional weight loss of 10 pounds in one month. Laboratory work-up showed a markedly elevated plasma metanephrine level of 4463.4 pmol/L (normal range <510 pmol/L). Since it is important to find the location, rule out malignant pheochromocytoma, and consider preoperative strategy, imaging studies were performed. Abdominal ultrasound revealed a hypervascular mass in the right adnexa, while an MRI of the abdomen and pelvis identified a lobulated soft tissue mass in the right hemipelvis with diffusion restriction that appeared to be arising from the urinary bladder. Given the clinical presentation, significant elevation in catecholamines, and MRI results, extra-adrenal pheochromocytoma (EAP) was the leading differential diagnosis. Phenoxybenzamine was initiated to control her blood pressure and a partial cystectomy was performed to excise the tumor involving the right posterolateral bladder wall. Histopathological report from urinary bladder tissue biopsy confirmed the diagnosis of EAP. This case highlights a rare and intriguing presentation of EAP arising from the urinary bladder, successfully managed with partial cystectomy.

2024-12-03·Endocrine Oncology

A rare case of bladder paraganglioma treated successfully with robotic partial cystectomy

Article

作者: Palan, Jessal M ; Chung, Teng-Teng ; Albor, Christo B ; Wan, Simon ; Shekhda, Kalyan M

Summary:

Bladder paragangliomas are rare extra-adrenal urological tumors that account for around 0.05% of bladder cancers. Their diagnosis is often delayed because of the rarity of these tumors. There is a risk of an intraoperative hypertensive crisis if not diagnosed or identified before surgical removal. We describe a case of a 36-year-old lady presented with a 10-year history of post-micturition palpitations and headaches. Her biochemical workup showed raised urinary normetanephrine levels and imaging showed a 123I MIBG-avid bladder mass compatible with bladder paraganglioma, although interestingly almost no tracer was picked up in 68Ga DOTATATE imaging. She was started on phenoxybenzamine to control her blood pressure prior to surgery. She underwent a successful robotic partial cystectomy with no complications. After surgery, she remained symptom-free. Bladder paragangliomas are rare neuroendocrine tumors of the bladder, which need to be diagnosed and managed effectively to avoid intraoperative and long-term complications.

Learning points:

It is important for patients with a bladder lesion to have a comprehensive differential assessment and biochemical and radiological investigations including functional imaging.Multiple imaging modalities along with what is available are useful in the assessment of bladder paraganglioma.The key role of the multidisciplinary team is to plan treatment in the perioperative period for minimizing risk, especially in situations where optimal management is actively debated.

项与盐酸酚苄明相关的新闻（医药）

2022-12-13

·米内网

【瞩目】科伦发威！进攻10亿大品种

精彩内容12月12日，CDE官网显示，科伦药业以仿制4类报产的盐酸乌拉地尔注射液获得承办受理。盐酸乌拉地尔注射液为静脉降压药，2021年在中国公立医疗机构终端销售额突破10亿元。乌拉地尔是一种选择性α1受体阻滞剂，具有外周和中枢双重降压作用。盐酸乌拉地尔注射液主要适用于高血压危象以及控制围手术期高血压，在临床上应用甚广，是急诊室常备急救药品之一。米内网数据显示，2021年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端乌拉地尔注射剂销售规模接近15亿元，同比增长14.64%。其中，盐酸乌拉地尔注射液销售额首次突破10亿元，同比增长18.61%。中国公立医疗机构终端盐酸乌拉地尔注射液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前，国内已上市的乌拉地尔制剂包括盐酸乌拉地尔注射液、注射用盐酸乌拉地尔、乌拉地尔注射液、乌拉地尔缓释片、乌拉地尔缓释胶囊、乌拉地尔葡萄糖注射液、乌拉地尔氯化钠注射液。科伦药业获批上市的高血压用药来源：米内网新版数据库在高血压用药领域，科伦药业累计已有10个品种获批上市，包括阿替洛尔片、注射用呋塞米、盐酸酚苄明片、注射用硝普钠、盐酸拉贝洛尔片、替米沙坦片、替米沙坦胶囊、尼群地平片、尼莫地平片、尼莫地平注射液。数据来源：米内网数据库、CDE注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

上市批准专利侵权

100 项与盐酸酚苄明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00507	盐酸酚苄明	C04AX02	DB00925

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
外周血管痉挛性疾病	中国	苏州弘森药业股份有限公司	1987-01-01
尿潴留	中国	苏州弘森药业股份有限公司	1987-01-01
高血压	美国	Advanz Pharma Corp. Ltd.	1953-01-26
高血压	美国	Concordia Pharmaceuticals, Inc.	1953-01-26
嗜铬细胞瘤	美国	Advanz Pharma Corp. Ltd.	1953-01-26
嗜铬细胞瘤	美国	Concordia Pharmaceuticals, Inc.	1953-01-26

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00620945 (CTgov)	N/A	先天性心脏缺损	87	Phenoxybenzamine (Phenoxybenzamine Treatment)	餘選積選窪網淵遞鏇鑰(獵繭醖築醖餘醖積齋繭) = 艱遞築蓋淵蓋願網鬱壓壓築鑰齋積衊餘膚築廠 (糧窪鑰窪遞觸願壓窪範, 襯網鏇淵獵窪壓構鹹顧 ~ 蓋遞鏇鹽鬱繭範淵齋選) 更多	-	2017-11-20
NCT00620945 (CTgov)	N/A	先天性心脏缺损	87	Phenoxybenzamine (Phenoxybenzamine)	遞簾簾觸蓋積夢廠繭鬱(壓膚餘選製範觸顧壓壓) = 膚醖糧鏇廠獵蓋遞襯壓範築獵範繭範糧繭簾窪 (顧構壓淵鏇齋範淵網鑰, 齋繭鑰襯鹽觸觸鹽構構 ~ 獵鏇艱廠範製遞鏇範膚) 更多	-	2017-11-20
NCT00569855 (CTgov)	临床2期	心脏病	785	phenoxybenzamine	壓淵構鏇顧憲鑰願廠鹽(觸淵鏇齋鬱廠齋衊鏇憲) = 淵糧鹽窪膚蓋鬱選獵艱築鏇積襯膚廠網窪糧範 (願築築鑰醖願糧鹹鑰糧, 膚壓簾積築廠鑰齋選襯 ~ 顧獵蓋鬱簾獵繭醖鹹淵) 更多	-	2011-03-01