NCT07788300

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

August 26, 2026

Status Verified

August 1, 2026

Enrollment Period

2.2 years

First QC Date

August 23, 2026

Last Update Submit

August 23, 2026

Conditions

Skull Base Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Extent of lesion resection

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

    2 years

Study Arms (1)

skull base lesions

EXPERIMENTAL

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

Procedure: Endoscopic Endonasal Approach for Skull Base Lesions.

Interventions

Endoscopic Endonasal Approach for Skull Base Lesions.PROCEDURE

Surgical Outcomes of Extended Endoscopic Endonasal Approach for Skull Base Lesions

skull base lesions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.
  • \. Patients undergoing lesion resection using the extended endoscopic endonasal approach (EEEA).
  • \. 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.
  • \. Availability of early postoperative MRI (within 72 hours to 3 months) to assess the extent of resection.
  • \. Patients with adequate postoperative follow-up (minimum 3 months) for evaluation of outcomes and complications.

You may not qualify if:

  • \. 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.
  • \. Patients with incomplete clinical, radiological, or operative data. 5. Absence of early postoperative MRI, making assessment of the extent of resection unreliable.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 19650013RESULT

  • 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.

    PMID: 22858054RESULT

Related Links

MeSH Terms

Conditions

Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Skull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Central Study Contacts

Amr Gamal Hussein, specialties

CONTACT

01067651618amrgamalz@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 23, 2026

First Posted

August 26, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

August 26, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

publication (41261509)Access

Locations

EG(1)