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临床试验/NCT02357498
NCT02357498已完成不适用

Prospective Multicenter Cohort Study Comparing Extent of Tumor Resection Between Microscopic Transsphenoidal Surgery and Fully Endoscopic Transsphenoidal Surgery for Nonfunctioning Pituitary Adenomas

St. Joseph's Hospital and Medical Center, Phoenix7 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2015年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
260
试验地点
7
主要终点
percentage of patients who have complete tumor removal (gross total resection) based on MRI .

研究概览

简要总结

The purpose of this research study is to compare the extent of resection (EOR) in patients with nonfunctioning pituitary adenomas undergoing transsphenoidal surgery using a microsurgical technique to those patients who have undergone surgery with a fully endoscopic technique. Another goal is to compare surgical complications, endocrine outcomes, visual outcomes, length of surgery, length of hospital stay, and readmission rates between the two transsphenoidal surgery techniques. This is an observational data collection study with no experimental procedures or experimental medicines. Endonasal transsphenoidal removal of a pituitary tumor is a unique procedure and there is little information comparing the two surgical techniques.

详细描述

The treatment of choice for most patients with symptomatic nonfunctioning pituitary adenomas is transsphenoidal surgery to improve vision by decompression of the optic chiasm, to prevent the development of endocrine dysfunction, and to treat neurological symptoms such as headache or cranial neuropathies caused by the tumor. The most widely accepted surgical technique is microscopic transsphenoidal surgery, in which an operating microscope is used by the surgeon to provide surgical visualization and a nasal speculum is used to maintain the operative corridor. [1-4] Recently, fully endoscopic transsphenoidal surgery, in which surgical visualization is achieved using an endoscope, has been adopted by many pituitary surgeons because the technique offers superior panoramic and angled visualization of the surgical target and may permit greater tumor resection. [5-10] There is a vigorous debate in the neurosurgical community about the relative merits of the microscopic and endoscopic techniques. Proponents of the endoscopic technique argue that the superior visualization permits more aggressive tumor resection and better preservation of the normal pituitary gland. Proponents of the microscopic technique argue that it permits shorter operative times, results in similar surgical outcomes, and has a lower complication rate.

Despite the adoption of fully endoscopic surgery by many surgeons, no prospective studies have compared the extent of tumor resection (EOR) between microscopic and endoscopic approaches. Numerous retrospective studies have established the efficacy of each approach, but only a few studies present comparative data.[11-13] Recently, McLaughlin et al. noted that the addition of endoscopy to microscopic pituitary surgery enhances tumor removal, particularly in patients with tumors greater than 20 mm in diameter. [14] This study raises the intriguing possibility that certain subgroups of patients (e.g. patients with larger tumors) may benefit from endoscopic surgery. In patients with smaller tumors with no cavernous sinus invasion, others have shown that the techniques achieve similar EOR. [15] That endoscopy may permit more complete tumor resections is a testable hypothesis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with suspected nonfunctioning pituitary macroadenomas (≥ 1 cm) with planned transsphenoidal surgery
  • •Adults (age 18-80 years)
  • •Medically stable for surgery
  • •Reasonable expectation that patient will complete study and be available for follow-up assessments

排除标准

  • •Prisoners
  • •Pregnant women
  • •Patients with suspected functioning pituitary adenoma
  • •Unable to obtain MRI of the pituitary (e.g., pacemaker, anaphylaxis to gadolinium, low GFR)
  • •Pituitary apoplexy

研究组 & 干预措施

microscopic

Active Comparator

Microscopic transsphenoidal surgery, including endoscopic-assisted approach (350 subjects)

干预措施: transsphenoidal surgery (Procedure)

endoscopic

Active Comparator

Fully endoscopic transsphenoidal surgery (350 subjects)

干预措施: transsphenoidal surgery (Procedure)

结局指标

主要结局

percentage of patients who have complete tumor removal (gross total resection) based on MRI .

时间窗: 3 months post surgery

Postop MRI read by neuroradiologist

次要结局

  • hypothyroidism(6 months post surgery)
  • volume of residual tumor(3 months after date of surgery)
  • percentage of tumor removed(3 months post surgery)
  • growth hormone deficiency(6 months post surgery)
  • postoperative cerebral-spinal fluid (CSF) leak(6 months (continuous) from surgery)
  • hypopituitarism(6 months post surgery)
  • visual outcomes(3 months post surgery)
  • postoperative meningitis(6 months (continuous) from surgery)
  • diabetes insipidus (DI)(6 months post surgery)
  • hypogonadism(6 months post surgery)
  • adrenal insufficiency(6 months post surgery)

研究者

发起方
St. Joseph's Hospital and Medical Center, Phoenix
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pam Dewey

Clinical Research Operations Manager

St. Joseph's Hospital and Medical Center, Phoenix

研究点 (7)

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