The Impact of Endoscopic Endonasal Skull Base Surgery on Olfaction

NCT06874426 | Recruiting

• 1 other identifier: S69823
• Study Type: observational
• Target: 154
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Meningioma; Pituitary Disease; Pituitary Adenoma; Craniopharyngioma; Endoscopic Pituitary Surgery; Olfactory Dysfunction

Keywords

olfactory dysfunction; trigeminal dysfunction; endoscopic endonasal skull base surgery; pituitary surgery

Outcome Measures

Primary Outcomes (3)

• Incidence of olfactory dysfunction

  From enrollment to the last evaluation 6 months postoperatively

• Incidence of trigeminal dysfunction

  From enrollment to the last evaluation 6 months postoperatively

• Etiology of olfactory and trigeminal dysfunction following endoscopic endonasal skull base surgery

  Until the end of study (at 3 years)

Secondary Outcomes (1)

• Risk factors for olfactory dysfunction following endoscopic endonasal skull base surgery

  From enrollment to the last evaluation 6 months postoperatively

Interventions

Endoscopic endonasal skull base surgery PROCEDURE

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

Also known as: endoscopic pituitary surgery, anterior skull base surgery

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with an indication for endoscopic endonasal skull base surgery for lesions in the anterior skull base (the parasellar region)

You may qualify if:

• Adult patients scheduled for endoscopic endonasal skull base surgery

You may not qualify if:

• Pre-existing anosmia
• Patients has a history of previous endoscopic endonasal skull base surgery

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (3)

KU Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Max Planck Research Unit for Neurogenetics

Frankfurt am Main, Hesse, 69, Germany

ACTIVE NOT RECRUITING

Leiden University Medical Center

Leiden, South Holland, 10702, Netherlands

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mucosa of the posterior part of the septum

MeSH Terms

Conditions

Meningioma; Pituitary Diseases; Pituitary Neoplasms; Craniopharyngioma

Condition Hierarchy (Ancestors)

Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Nervous System Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal

Central Study Contacts

Julie van Waterschoot

CONTACT

+32477910294; julie.vanwaterschoot@kuleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: March 13, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): September 1, 2029
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

DE (1); NL (1); BE (1)