Clinical Trials Directory

Trials / Completed

CompletedNCT03624114

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

Prediction of Sphenoid Septation in Magnetic Resonance Imaging Compared With Computed Tomography and Intraoperative Findings During Endoscopic Pituitary Adenoma Surgery - a Prospective Observational Study

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREcomparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgeryA comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.

Timeline

Start date
2018-01-01
Primary completion
2021-12-31
Completion
2021-12-31
First posted
2018-08-09
Last updated
2022-08-03

Locations

2 sites across 2 countries: Malaysia, Switzerland

Source: ClinicalTrials.gov record NCT03624114. Inclusion in this directory is not an endorsement.