MeningiomaEndo-OlfactNCT06874426
The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
An observational study of Meningioma and Pituitary Disease, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
Trial summary
In this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Meningioma, Pituitary Disease, Pituitary Adenoma
- What is being tested?
- Endoscopic endonasal skull base surgery
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 18 Mar 2025to Sep 2029
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)
Who may be able to join
- Adult patients scheduled for endoscopic endonasal skull base surgery
Who cannot join
- Pre-existing anosmia
- Patients has a history of previous endoscopic endonasal skull base surgery
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Belgium1 site, 1 recruiting
- Recruiting
KU Leuven
Leuven, Vlaams-Brabant, 3000
Julie van Waterschoot, 0477910294, julie.vanwaterschoot@kuleuven.be
Julie van Waterschoot
Germany1 site
- Active, not recruiting
Max Planck Research Unit for Neurogenetics
Frankfurt am Main, Hesse, 69
Netherlands1 site, 1 recruiting
- Not yet recruiting
Leiden University Medical Center
Leiden, South Holland, 10702
Maarten Kleijwegt, 0477910294, m.c.kleijwegt@lumc.nl
Maarten Kleijwegt
About this study
In this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis.
Read the detailed description
The incidence of olfactory dysfunction following endoscopic endonasal skull base surgery remains unclear in current research, and the results vary widely. Additionally, the pathophysiology of this postoperative olfactory dysfunction and the impact of this surgery on the trigeminal system has not been investigated to date. In this study, the investigators developed a state-of-the-art clinical pipeline with olfactory and trigeminal assessments, prior to and following endoscopic endonasal skull base surgery. Furthermore, the investigators will collect surgical waste tissue from the posterior septal mucosa, which is removed during this procedure to gain access to the sphenoid sinus and the (para)sellar region. By performing histomolecular analysis, the research group aims to elucidate the pathophysiology of olfactory dysfunction following this surgery.
- Conditions
- Meningioma, Pituitary Disease, Pituitary Adenoma, Craniopharyngioma, Endoscopic Pituitary Surgery, Olfactory Dysfunction
- Being tested
- Endoscopic endonasal skull base surgery
- Keywords
- olfactory dysfunction, trigeminal dysfunction, endoscopic endonasal skull base surgery, pituitary surgery
- Medical subject headings
- Meningioma, Pituitary Diseases, Pituitary Neoplasms, Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic endonasal skull base surgeryProcedure or surgery
Also called endoscopic pituitary surgery, anterior skull base surgery
This intervention will be performed as part of the standard-of-care for patients scheduled for endoscopic endonasal skull base surgery for lesions in the (para)sellar region
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of olfactory dysfunction
Measured: From enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunction
Measured: From enrollment to the last evaluation 6 months postoperatively
Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery
Measured: Until the end of study (at 3 years)
Secondary outcomes (1)
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery
Parameters such as smoking history, allergies, age, gender, co-morbidities will be investigated as possible covariates
Measured: From enrollment to the last evaluation 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start18 Mar 2025
- Primary completionDec 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeningiomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874426
- Sponsor's protocol ID
- S69823
- Acronym
- Endo-Olfact
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction
- ClinicalTrials.gov ID
- NCT06874426
- Acronym / sponsor ID
- Endo-Olfact / S69823
- Conditions
- Meningioma, Pituitary Disease, Pituitary Adenoma, Craniopharyngioma, Endoscopic Pituitary Surgery, Olfactory Dysfunction
- Keywords
- olfactory dysfunction, trigeminal dysfunction, endoscopic endonasal skull base surgery, pituitary surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 13 Mar 2025 (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.
In this study, the research team will investigate the incidence and etiology of olfactory dysfunction following endoscopic endonasal skull base surgery, by combining clinical assessments with histomolecular analysis.
Detailed description
The incidence of olfactory dysfunction following endoscopic endonasal skull base surgery remains unclear in current research, and the results vary widely. Additionally, the pathophysiology of this postoperative olfactory dysfunction and the impact of this surgery on the trigeminal system has not been investigated to date. In this study, the investigators developed a state-of-the-art clinical pipeline with olfactory and trigeminal assessments, prior to and following endoscopic endonasal skull base surgery. Furthermore, the investigators will collect surgical waste tissue from the posterior septal mucosa, which is removed during this procedure to gain access to the sphenoid sinus and the (para)sellar region. By performing histomolecular analysis, the research group aims to elucidate the pathophysiology of olfactory dysfunction following this surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)
Key inclusion criteria (1 listed)
- Adult patients scheduled for endoscopic endonasal skull base surgery
Key exclusion criteria (2 listed)
- Pre-existing anosmia
- Patients has a history of previous endoscopic endonasal skull base surgery
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 skull base surgeryAlso: endoscopic pituitary surgery, anterior skull base surgeryThis intervention will be performed as part of the standard-of-care for patients scheduled for endoscopic endonasal skull base surgery for lesions in the (para)sellar region | Procedure or surgery | – |
Primary outcome
Incidence of olfactory dysfunction
Time frame: From enrollment to the last evaluation 6 months postoperatively
Incidence of trigeminal dysfunction
Time frame: From enrollment to the last evaluation 6 months postoperatively
Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery
Time frame: Until the end of study (at 3 years)
1 secondary outcome
Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery
Time frame: From enrollment to the last evaluation 6 months postoperatively
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 23 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meningioma and Pituitary Disease, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 3 countries.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Germany, Netherlands. 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 Julie van Waterschoot (+32477910294, julie.vanwaterschoot@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of olfactory dysfunction (time frame: From enrollment to the last evaluation 6 months postoperatively). The study lists 3 primary outcomes in all. 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 23 Apr 2025.