Endoscopic Pituitary Transnasal ApproachNCT07907380
Endoscopic Pituitary Lesions Transnasal Approach and Minimally Invasive Eyebrow Incision Approach
An observational study of Endoscopic Pituitary Transnasal Approach and Minimally Invasive Eyebrow Incision, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of endoscopic transnasal approach versus minimally invasive eyebrow incision approach for pituitary lesions in terms of safety, efficacy and postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Pituitary Transnasal Approach, Minimally Invasive Eyebrow Incision
- What is being tested?
- Endoscopic Transnasal Approach and Minimally Invasive Eyebrow Approach
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective comparative study will be conducted on 60 patients with selected pituitary lesions who underwent surgical treatment through either an endoscopic transnasal approach or a minimally invasive eyebrow incision approach at the Neurosurgery Department of KafrElsheikh University Hospitals. The study will include patients treated during the period from January 2022 to August 2026.
Who may be able to join
- Adult patients aged ≥18 years.
- Both sexes.
- Patients with selected pituitary lesions requiring surgical treatment.
- Sellar or sellar and suprasellar lesions suitable for either surgical approach.
- Patients with visual symptoms or radiological compression of the optic apparatus.
Who cannot join
- Previous surgery for the same lesion.
- Recurrent or residual lesions require complex revision surgery.
- Extensive lateral or vascular extension unsuitable for either approach.
- Lesions require a combined or staged approach.
- Active infection.
- Severe uncontrolled comorbidities contraindicating surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Endoscopic Pituitary Lesions Transnasal Approach and Minimally Invasive Eyebrow Incision Approach
This study aims to compare the effect of endoscopic transnasal approach versus minimally invasive eyebrow incision approach for pituitary lesions in terms of safety, efficacy and postoperative recovery.
Read the detailed description
Pituitary lesions represent an important group of sellar and parasellar pathologies that may produce visual, neurological, and endocrinological manifestations. Surgical treatment is indicated in selected patients, particularly those with visual pathway compression, progressive neurological manifestations, hormonal hypersecretion, or lesions causing significant mass effect.
The endoscopic transnasal approach provides a direct route to the sellar region through the nasal cavity and sphenoid sinus, avoiding transcranial exposure and minimizing manipulation of the cerebral hemispheres.
The minimally invasive eyebrow approach may be particularly useful when the lesion has significant suprasellar or anterior extension that can be accessed directly through a low subfrontal trajectory.
- Being tested
- Endoscopic Transnasal Approach, Minimally Invasive Eyebrow Approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Transnasal ApproachProcedure or surgery
Patients underwent endoscopic transnasal transsphenoidal surgery for removal of the pituitary lesion.
Minimally Invasive Eyebrow ApproachProcedure or surgery
Patients underwent minimally invasive supraorbital eyebrow incision surgery for removal of the pituitary lesion.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Endoscopic Transnasal Approach) | Patients underwent endoscopic transnasal transsphenoidal surgery for removal of the pituitary lesion. Receives: Procedure: Endoscopic Transnasal Approach | |
| Group B (Minimally Invasive Eyebrow Approach) | Patients underwent minimally invasive supraorbital eyebrow incision surgery for removal of the pituitary lesion. Receives: Procedure: Minimally Invasive Eyebrow Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Tumor Resection Rate
Percentage of patients achieving successful tumor resection following endoscopic transnasal surgery or minimally invasive supraorbital eyebrow surgery, assessed using postoperative contrast-enhanced sellar magnetic resonance imaging (MRI).
Measured: 3 months after surgery
Secondary outcomes (8)
Visual Improvement Rate
Percentage of patients with improvement in visual acuity and/or visual fields compared with preoperative findings, based on documented ophthalmological assessments.
Measured: 3 months after surgery
Endocrinological Improvement Rate
Percentage of patients with improvement of preoperative hormonal abnormalities, assessed using documented postoperative hormonal investigations and endocrinological assessments. Criteria for improvement and remission will be specified for each hormonal disorder.
Measured: 3 months after surgery
Estimated Intraoperative Blood Loss
Estimated volume of blood lost during surgery was expressed in milliliters and recorded.
Measured: Intraoperatively
Degree of pain
Degree of pain was assessed using documented Visual Analog Scale scores ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: 3 months after surgery
Incidence of Postoperative Hemorrhage
Percentage of patients with postoperative hemorrhage was documented.
Measured: 3 months after surgery
Incidence of Postoperative Wound Complications
Incidence of postoperative wound complications were recorded.
Measured: 3 months after surgery
Incidence of Residual Tumor
Percentage of patients with residual tumor identified on postoperative contrast-enhanced sellar magnetic resonance imaging.
Measured: 3 months after surgery
Incidence of Tumor Recurrence
Percentage of patients with reappearance of tumor on follow-up contrast-enhanced sellar magnetic resonance imaging after previously documented complete resection.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Jan 2022
- Primary completion1 Aug 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Pituitary Transnasal ApproachStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed Basha, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907380
- Sponsor's protocol ID
- KFSIRB200-1234
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Endoscopic Pituitary Lesions Transnasal Approach and Minimally Invasive Eyebrow Incision Approach
- ClinicalTrials.gov ID
- NCT07907380
- Acronym / sponsor ID
- KFSIRB200-1234
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 30 Oct 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.
This study aims to compare the effect of endoscopic transnasal approach versus minimally invasive eyebrow incision approach for pituitary lesions in terms of safety, efficacy and postoperative recovery.
Detailed description
Pituitary lesions represent an important group of sellar and parasellar pathologies that may produce visual, neurological, and endocrinological manifestations. Surgical treatment is indicated in selected patients, particularly those with visual pathway compression, progressive neurological manifestations, hormonal hypersecretion, or lesions causing significant mass effect.
The endoscopic transnasal approach provides a direct route to the sellar region through the nasal cavity and sphenoid sinus, avoiding transcranial exposure and minimizing manipulation of the cerebral hemispheres.
The minimally invasive eyebrow approach may be particularly useful when the lesion has significant suprasellar or anterior extension that can be accessed directly through a low subfrontal trajectory.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Endoscopic Transnasal Approach) | – | Procedure: Endoscopic Transnasal ApproachPatients underwent endoscopic transnasal transsphenoidal surgery for removal of the pituitary lesion. |
| Group B (Minimally Invasive Eyebrow Approach) | – | Procedure: Minimally Invasive Eyebrow ApproachPatients underwent minimally invasive supraorbital eyebrow incision surgery for removal of the pituitary lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective comparative study will be conducted on 60 patients with selected pituitary lesions who underwent surgical treatment through either an endoscopic transnasal approach or a minimally invasive eyebrow incision approach at the Neurosurgery Department of KafrElsheikh University Hospitals. The study will include patients treated during the period from January 2022 to August 2026.
Key inclusion criteria (5 listed)
- Adult patients aged ≥18 years.
- Both sexes.
- Patients with selected pituitary lesions requiring surgical treatment.
- Sellar or sellar and suprasellar lesions suitable for either surgical approach.
- Patients with visual symptoms or radiological compression of the optic apparatus.
Key exclusion criteria (6 listed)
- Previous surgery for the same lesion.
- Recurrent or residual lesions require complex revision surgery.
- Extensive lateral or vascular extension unsuitable for either approach.
- Lesions require a combined or staged approach.
- Active infection.
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 Transnasal ApproachPatients underwent endoscopic transnasal transsphenoidal surgery for removal of the pituitary lesion. | Procedure or surgery | Group A (Endoscopic Transnasal Approach) |
| Minimally Invasive Eyebrow ApproachPatients underwent minimally invasive supraorbital eyebrow incision surgery for removal of the pituitary lesion. | Procedure or surgery | Group B (Minimally Invasive Eyebrow Approach) |
Primary outcome
Successful Tumor Resection Rate
Time frame: 3 months after surgery
Percentage of patients achieving successful tumor resection following endoscopic transnasal surgery or minimally invasive supraorbital eyebrow surgery, assessed using postoperative contrast-enhanced sellar magnetic resonance imaging (MRI).
8 secondary outcomes
Visual Improvement Rate
Time frame: 3 months after surgery
Endocrinological Improvement Rate
Time frame: 3 months after surgery
Estimated Intraoperative Blood Loss
Time frame: Intraoperatively
Degree of pain
Time frame: 3 months after surgery
Incidence of Postoperative Hemorrhage
Time frame: 3 months after surgery
Incidence of Postoperative Wound Complications
Time frame: 3 months after surgery
Incidence of Residual Tumor
Time frame: 3 months after surgery
Incidence of Tumor Recurrence
Time frame: 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Pituitary Transnasal Approach and Minimally Invasive Eyebrow Incision, run by Kafrelsheikh 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 6 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: finished, as of the sponsor's last update on 30 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Tumor Resection Rate (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.