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

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

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.

Study Overview

• Status: Completed
• Conditions: Pituitary Adenoma
• Intervention / Treatment: Procedure: comparison of data from MRI with data from CT compared with intraoperative data from endoscopic 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Malaysia
  • Petaling Jaya, Malaysia, 59100
    • University of Malaya Medical Center and Specialist Center
• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel, Neurochirurgie und Spinale Chirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Michel Röthlisberger, Dr. med, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ACTUAL): December 31, 2021
• Study Completion (ACTUAL): December 31, 2021

Study Registration Dates

• First Submitted: August 7, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: pituitary adenoma surgery; endoscopic transsphenoidal surgery; sphenoid septation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Adenoma; Pituitary Neoplasms; Pituitary Diseases
• Other Study ID Numbers: 2018-00065; ch18Roethlisberger

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No