- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07788300
Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amr Gamal Hussein, specialties
- Phone Number: 01067651618
- Email: amrgamalz@yahoo.com
Study Locations
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Asyut, Egypt
- Assiut University
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Contact:
- Assiut University Assiut Assiut University, Assiut University
- Phone Number: Assiut University
- Email: vp_grad@aun.edu.eg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
1. Adult patients aged 18 years or older. 2. 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 5. Availability of complete preoperative assessment, including: Clinical evaluation Neuro-ophthalmological assessment (when applicable) Radiological imaging 6. 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.
Exclusion Criteria:
1. Patients aged less than 18 years. 2. Patients who underwent transcranial approaches. 3. Lesions not primarily involving the skull base or not suitable for endoscopic endonasal access.
4. Patients with incomplete clinical, radiological, or operative data. 5. Absence of early postoperative MRI, making assessment of the extent of resection unreliable.
6. Patients with insufficient follow-up (less than 3 months). 7. Cases managed by biopsy only without attempted lesion resection. 8. Patients with severe comorbidities significantly affecting surgical outcome (e.g., advanced systemic disease), if they introduce bias in outcome assessment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: skull base lesions
Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions.
|
Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Extent of lesion resection
Time Frame: 2 years
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Extent of lesion resection (Gross total resection vs Subtotal resection) based on postoperative MRI
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2 years
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Arbolay OL, Gonzalez JG, Gonzalez RH, Galvez YH. Extended endoscopic endonasal approach to the skull base. Minim Invasive Neurosurg. 2009 Jun;52(3):114-8. doi: 10.1055/s-0028-1119414. Epub 2009 Jul 31.
- Lopez-Arbolay O, Gonzalez-Gonzalez J, Rojas-Manresa JL. [Extended endoscopic endonasal approach to skull base]. Neurocirugia (Astur). 2012 Nov;23(6):219-25. doi: 10.1016/j.neucir.2012.05.003. Epub 2012 Aug 1. Spanish.
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Skull base lesions
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Study Data/Documents
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publication
Information identifier: 41261509Information comments: no comments
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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