Clinical trial NCT03624114: Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery
Official title: Prediction of Sphenoid Septation in Magnetic Resonance Imaging Compared With Computed Tomography and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery - a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pituitary Adenoma
Keywords: pituitary adenoma surgery
endoscopic transsphenoidal surgery
sphenoid septation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-08-09
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with sphenoidal surgery for an anterior skull base tumor with preoperative MRI, CT and intraoperative video during endoscopy (Centre A) and preoperative MRI and intraoperative video during endoscopy (Centre B).

Consecutive recruitment of patients with planned endonasal endoscopic anterior skullbase tumors in daily clinical practice in both centres (A and B).

Brief summary: To investigate whether MRI is able to predict the exact anatomy and topography of the sphenoid sinus and its relationship to the sellar, parasellar und paraclinoid region and where CT yields more detailed information for the surgeon before trans-sphenoidal pituitary adenoma surgery.

Detailed description: The current research project addresses the question whether MRI alone is sufficient for preoperative planning and computer-assisted surgery (CAS) during standard trans-sphenoidal pituitary surgery and if situations can be identified, where additional CT yields more information for the surgeon.

A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.

50 patients operated the University hospital of Basel \[USB\] (Centre A) are consecutively included into the prospective part of the study. MRI is used to assess the standardized variables, confirmed by CT. Additionally, for the 50 prospectively collected patients, neuroimaging results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Between 20-50 patients operated at the University of Malaya Medical Centre \[UMMC\] and Specialist Centre \[UMSC\] (Centre B)will be included retro- and prospectively . MRI is used to assess the standardized variables and the results are correlated with intraoperative evaluation during endoscopic trans-sphenoidal surgery or post-hoc with video analysis of the performed surgery.

Eligibility criteria: Inclusion Criteria:

* lndicated trans-nasal trans-sphenoidal surgery for an anterior skull base tumour with preoperative baseline MRI (Centre A and B) and baseline CT (Centre A).

Exclusion Criteria:

* Previous trans-sphenoidal surgery
* Patients without CT, MRI or intraoperative endoscopic video

Primary outcomes:
measure: Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess
timeFrame: duration of endoscopic transsphenoidal surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Petaling Jaya
country: Malaysia
facility: University of Malaya Medical Center and Specialist Center
city: Basel
country: Switzerland
facility: University Hospital Basel, Neurochirurgie und Spinale Chirurgie
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Michel Röthlisberger, Dr. med
role: PRINCIPAL_INVESTIGATOR
References: