Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
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About
Pituitary adenoma can be difficult to cure with approximately a third of patients in contemporary series' undergoing incomplete resection. Over the last decade or so a handful of groups have described the use intraoperative ultrasound to improve resection. Although limited, these proof-of-concept studies suggest intraoperative ultrasound is a safe and effective technological adjunct to transsphenoidal surgery for pituitary adenoma.
In this prospective development study 30 adult patients will undergo transsphenoidal surgery for pituitary adenoma with prototype intraoperative ultrasound devices. The primary outcomes will be technical feasibility and device safety. The secondary outcomes will be complete versus incomplete radiological resection, endocrinological remission, the occurrence of postoperative complications, operating time, and length of stay.
Enrollment
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Volunteers
Inclusion criteria
- adult patients
- undergoing transsphenoidal surgery
- diagnosis of pituitary adenoma on pre-operative MRI
- able to provide consent
Exclusion criteria
- patients less than 18 years of age
- patients undergoing transcranial surgery
- diagnosis other than that of pituitary adenoma on pre-operative MRI e.g., meningioma
- unable to provide consent e.g., mental illness or later withdrawing consent.
Trial design
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Interventional model
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Data sourced from clinicaltrials.gov
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