Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

Pituitary Adenoma Clinical Trial

Official title:

Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03284775
• Other study ID #: 17/0310
• Status: Completed
• Phase: N/A
• Start date: August 7, 2019
• Est. completion date: August 2, 2023

Study information

• Verified date: November 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2, 2023
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Pituitary Adenoma
• Pituitary Diseases
• Pituitary Neoplasms

Intervention

Device:
• Intraoperative ultrasound
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.

Locations

Country	Name	City	State
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Operating time (minutes)		Intra-operative
Secondary	Length of stay (days)		Early post-operative