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

NCT03624114 | Completed

• 1 other identifier: 2018-00065; ch18Roethlisberger
• Study Type: observational
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

Pituitary Adenoma

Keywords

pituitary adenoma surgery; endoscopic transsphenoidal surgery; sphenoid septation

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgery PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

University of Malaya Medical Center and Specialist Center

Petaling Jaya, 59100, Malaysia

Location

University Hospital Basel, Neurochirurgie und Spinale Chirurgie

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Michel Röthlisberger, Dr. med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 9, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

MY (1); CH (1)