Prediction of Sphenoid Septation in MRI Compared With CT and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery

Pituitary Adenoma Clinical Trial

— Scope  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624114
• Other study ID #: 2018-00065; ch18Roethlisberger
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Procedure:
• comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgery
A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Center and Specialist Center	Petaling Jaya
Switzerland	University Hospital Basel, Neurochirurgie und Spinale Chirurgie	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

Malaysia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior Insertion Site of the sphenoid septum at Cavernous Carotid and/or Optico-Carotid-Recess	To compare the relative performance of the MRI and the CT scan regarding posterior insertion site of the sphenoid septum at cavernous carotid and/or optico-carotid-recess. Neuroimaging results are correlated with intraoperative evaluation during endoscopic transsphenoidal surgery.	duration of endoscopic transsphenoidal surgery