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临床试验/NCT03624114
NCT03624114已完成不适用

Prediction of Sphenoid Septation in Magnetic Resonance Imaging Compared With Computed Tomography and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery - a Prospective Observational Study

University Hospital, Basel, Switzerland2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess

研究概览

简要总结

To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.

详细描述

The current research project addresses the question whether MRI alone is sufficient for preoperative planning and computer-assisted surgery (CAS) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional CT yields more information for the surgeon.

A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.

50 patients operated the University hospital of Basel [USB] (Centre A) are consecutively included into the prospective part of the study. MRI is used to assess the standardized variables, confirmed by CT. Additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Between 20-50 patients operated at the University of Malaya Medical Centre [UMMC] and Specialist Centre [UMSC] (Centre B)will be included retro- and prospectively . MRI is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline MRI (Centre A and B) and baseline CT (Centre A).

排除标准

  • Previous trans-sphenoidal surgery
  • Patients without CT, MRI or intraoperative endoscopic video

结局指标

主要结局

Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess

时间窗: duration of endoscopic transsphenoidal surgery

To compare the relative performance of the MRI and the CT scan regarding posterior insertion site of the sphenoid septum at cavernous carotid and/or optico-carotid-recess. Neuroimaging results are correlated with intraoperative evaluation during endoscopic transsphenoidal surgery.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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