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临床试验/NCT07788300
NCT07788300尚未招募不适用

Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions.

Assiut University0 个研究点目标入组 30 人开始时间: 2026年9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
30
主要终点
Extent of lesion resection

研究概览

简要总结

Aim of this study is to evaluate the surgical and functional outcomes of the extended endoscopic endonasal approach (EEEA) in the management of skull base lesions, including extent of resection, postoperative complications, and clinical outcomes.

详细描述

The extended endoscopic endonasal approach (EEEA) has emerged as a transformative technique in the surgical management of skull base lesions [1-3]. By utilizing natural nasal corridors, this minimally invasive approach provides direct midline access to a wide range of anterior, middle, and posterior skull base lesions, including pituitary adenomas, craniopharyngiomas, meningiomas, and chordomas [1,6]. Compared to traditional transcranial approaches, EEEA offers several advantages such as improved visualization with angled endoscopes, reduced brain retraction, and potentially lower morbidity [2,4].

Despite these advantages, achieving gross total resection (GTR) remains challenging and is influenced by multiple factors. Lesion characteristics such as size, location, consistency, and degree of invasion into critical neurovascular structures-particularly the cavernous sinus and internal carotid artery-play a crucial role [7,8]. Additionally, surgical factors including the chosen approach, reconstruction technique, and surgeon experience significantly impact the extent of resection and postoperative outcomes [4,5].

Understanding the predictors that influence the extent of resection is essential for optimizing surgical planning, improving patient outcomes, and minimizing complications such as cerebrospinal fluid leakage and neurological deficits [7]. Therefore, evaluating surgical outcomes and identifying key predictive factors in EEEA for skull base lesions remains an important area of ongoing research.

研究设计

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

入排标准

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

入选标准

  • 1. Adult patients aged 18 years or older.
  • Patients with radiologically confirmed skull base lesions (based on MRI ± CT) involving the anterior, middle, or posterior skull base.
  • 3. Patients undergoing lesion resection using the extended endoscopic endonasal approach (EEEA).
  • 4. Lesions amenable to endoscopic endonasal access, including: Pituitary adenomas with extrasellar extension Craniopharyngiomas Skull base meningiomas Chordomas and other midline skull base lesions
  • Availability of complete preoperative assessment, including: Clinical evaluation Neuro-ophthalmological assessment (when applicable) Radiological imaging
  • Availability of detailed intraoperative data, including surgical approach and intraoperative findings.
  • 7. Availability of early postoperative MRI (within 72 hours to 3 months) to assess the extent of resection.
  • 8. Patients with adequate postoperative follow-up (minimum 3 months) for evaluation of outcomes and complications.

排除标准

  • 1. Patients aged less than 18 years.
  • Patients who underwent transcranial approaches.
  • Lesions not primarily involving the skull base or not suitable for endoscopic endonasal access.
  • 4. Patients with incomplete clinical, radiological, or operative data.
  • Absence of early postoperative MRI, making assessment of the extent of resection unreliable.
  • 6. Patients with insufficient follow-up (less than 3 months).
  • Cases managed by biopsy only without attempted lesion resection.
  • Patients with severe comorbidities significantly affecting surgical outcome (e.g., advanced systemic disease), if they introduce bias in outcome assessment.

结局指标

主要结局

Extent of lesion resection

时间窗: 2 years

Extent of lesion resection (Gross total resection vs Subtotal resection) based on postoperative MRI

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

Amr Gamal Hussein Mohamed

Doctor

Assiut University

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