Skull Base NeoplasmsNCT07788300
Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions.
A study testing Endoscopic Endonasal Approach for Skull Base Lesions. in people with Skull Base Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Skull Base Neoplasms
- What is being tested?
- Endoscopic Endonasal Approach for Skull Base Lesions.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university
Asyut
Assiut University Assiut Assiut University, Assiut University, Assiut University, vp_grad@aun.edu.eg
About this study
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.
Read the 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.
- Conditions
- Skull Base Neoplasms
- Being tested
- Endoscopic Endonasal Approach for Skull Base Lesions.
- Medical subject headings
- Skull Base Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Endonasal Approach for Skull Base Lesions.Procedure or surgery
Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions
| Study group | Role | What they receive |
|---|---|---|
| skull base lesions | Experimental | Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions. Receives: Procedure: Endoscopic Endonasal Approach for Skull Base Lesions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent of lesion resection
Extent of lesion resection (Gross total resection vs Subtotal resection) based on postoperative MRI
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skull Base NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Gamal Hussein Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788300
- Sponsor's protocol ID
- Skull base lesions
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19650013Lopez-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.
PubMed 22858054
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions.
- ClinicalTrials.gov ID
- NCT07788300
- Acronym / sponsor ID
- Skull base lesions
- Conditions
- Skull Base Neoplasms
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| skull base lesions | Experimental | Procedure: Endoscopic Endonasal Approach for Skull Base Lesions.Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Endonasal Approach for Skull Base Lesions.Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions | Procedure or surgery | skull base lesions |
Primary outcome
Extent of lesion resection
Time frame: 2 years
Extent of lesion resection (Gross total resection vs Subtotal resection) based on postoperative MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Results publication: PubMed 19650013Arbolay 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.
- Results publication: PubMed 22858054Lopez-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.
- skull base tumorsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Endonasal Approach for Skull Base Lesions. in people with Skull Base Neoplasms, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Gamal Hussein, specialties (01067651618, amrgamalz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of lesion resection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788300, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.