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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative ultrasound | Device | Patients will undergo transsphenoidal surgery in the usual manner except that an intraoperative ultrasound device will be available for use to better visualise the tumour and surrounding neurovascular structures. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical feasibility | Technical feasibility will be assessed by the capacity of our system to provide ultrasound images of pituitary and adenoma tissue that correspond to pre- and post-operative MRI. | Intraoperative |
| Device safety | Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological resection | Radiological resection will be determined by a radiologist as gross total resection (GTR), subtotal resection (STR) when more than 80% of the tumour is resected, and partial resection when less than 80% of the tumour is resected.10 Residual tumour will be classified according to its location as intrasellar, suprasellar, intracavernous, or combined. | Early post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital for Neurology and Neurosurgery | London | United Kingdom |
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| ID | Term |
|---|---|
| D010911 | Pituitary Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007029 | Hypothalamic Neoplasms |
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| Endocrinological remission | Endocrinological remission will be determined by an endocrinologist. The criteria for acromegaly control will be normalisation of serum insulin-like growth factor and suppression of the nadir serum growth hormone level after oral glucose tolerance test. The criteria for Cushing's disease control will be normalisation of early morning serum cortisol and suppression of serum cortisol after low dose dexamethasone suppression test. The criteria for prolactinoma control will be normalisation of serum prolactin. | Early post-operative |
| Postoperative complications | Postoperative complications will include death, cerebrospinal fluid leak, meningitis, vascular complications, visual complications, diabetes insipidus transient and permanent, hypopituitarism, and cranial nerve injury. Vascular complications will include carotid or other vessel injury, or symptomatic haematoma. Venous bleeding from the cavernous sinus will be considered a vascular complication only if it prevents completion of the surgical procedure. Epistaxis will only be considered a vascular complication if it warrants return to the operating room. Cerebrospinal fluid leaks will include all postoperative leaks, and all patients who develop an intraoperative leak requiring lumbar drainage. Patients with Cushing's disease receiving postoperative cortisol, or in whom a hypophysectomy was carried out will also not be included as surgical complications. | Early post-operative |
| Operating time (minutes) | Intra-operative |
| Length of stay (days) | Early post-operative |
| D015173 |
| Supratentorial Neoplasms |
| D001932 | Brain Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D007027 | Hypothalamic Diseases |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |