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临床试验/NCT05338125
NCT05338125终止不适用

Identification of the Posterior Lobe of the Human Pituitary Gland During Surgery Using Its Electrophysiological, Neural Signature

Leiden University Medical Center2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
2
主要终点
Electrophysiological properties

研究概览

简要总结

Measurment of electrophysiological properties of the human pituitary gland during removal of a pituitary adenoma. Assessment if these properties are sufficient for intra-operative identification of different tissues.

详细描述

In this study, patients undergoing a surgical resection of a pituitary adenoma as part of standard care will undergo an extra measurement of the electrophysiological properties of the pituitary gland. A single-unit microlectrode will be introduced and placed in the adenoma tissue, anterior piuitary lobe and posterior pituitary lobe. Apart from this measurement, no other interventions are performed and standard care will continue. Six months after measurements the patients chart will be assessed for the occurrence of remission and endocrine deficiencies.

An assessment will be made if these properties are distinctive enough to allow intra-operative identification of the different tissues and thereby increase chances of maximal tumour removal and decrease chance of endocrine deficiencies.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Male and female patients undergoing transsphenoidal surgery for pituitary adenoma.
  • Identification of the posterior lobe on preoperative MRI. This is most common in patients with micro-adenomas or small macroadenomas.
  • Age >18 years

排除标准

  • Emergency surgery
  • Cognitive impairments
  • Pregnancy
  • Pre-existing diabetes insipidus

结局指标

主要结局

Electrophysiological properties

时间窗: Day 0

Electrophysiological properties of the human pituitary gland

次要结局

  • Endocrine remission(6 months postoperative)
  • Endocrine deficiencies(6 months postoperative)

研究者

发起方
Leiden University Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

wrvanfurth

MD, PhD

Leiden University Medical Center

研究点 (2)

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