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临床试验/NCT05801393
NCT05801393尚未招募不适用

Combined HRC, CT Cisternography and MR Cisternography in Assessment of Active CSF Rhinorrhes Compared to Operative Findings

Assiut University0 个研究点目标入组 50 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.

研究概览

简要总结

To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.

详细描述

CSF rhinorrhea is defined as passage of CSF from the subarachnoid space through osseous and dural defect at skull base into the nasal cavity.

Causes of CSF rhinorrhea are classified into traumatic (including iatrogenic) and non traumatic (including spontaneous leak).

Patients are presented by variable symptoms including clear nasal discharge, headache or with complications like meningitis or even brain abscess, so closure of the defect is of great importance with required accurate localization of the defect and its dimensions.

CSF rhinorrhea can be also classified into active when with active dripping or inactive when dripping is intermittent.

Different imaging modalities have been employed to localize and characterize skull base defects responsible for CSF leakage including computed tomography (CT), CT cisternography (CTC), magnetic resonance imaging (MRI), MR cisternography (MRC) and radionuclide cisternography (RNC). However, there is still no gold standard imaging modality.

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

  • (1) patients with active traumatic or non traumatic CSF leakage.
  • (2) patients with adequate organ function.

排除标准

  • (1) Patients known to have contrast hypersensitivity. (2) Patients with any general contraindication to MRI as presence of para magnetic substance as pacemakers or with claustrophobia.
  • (3) Patients with contraindication to lumbar puncture:
  • Infection near the puncture site, fever, sepsis.
  • New focal neurological signs or seizures.
  • Increased intra cranial tension.
  • Space occupying lesion.
  • Vertebral deformity, retropulsion, severe vertebral osteoarthritis or degenerative disc disease renders procedures more technically difficult.
  • Coagulopathy.
  • Patient refusal.

结局指标

主要结局

To assess the diagnostic accuracy of combined high resolution CT, CT cisternography and MR cisternography in pre operative assessment of active CSF leak, compared by endoscopic sinus surgery.

时间窗: from May 2023 to January 2025

Patients with persistent or intermittent CSF rhinorrhea will be scanned after a full clinical history with Oto-laryngological examination to confirm the presence of CSF leak

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ghada Abdelsabour Mohamed

GAMohamed

Assiut University

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