Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
Primary Purpose
Pituitary Adenoma
Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Intraoperative ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Pituitary Adenoma
Eligibility Criteria
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.
Sites / Locations
- National Hospital for Neurology and Neurosurgery
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Operating time (minutes)
Length of stay (days)
Full Information
NCT ID
NCT03284775
First Posted
September 12, 2017
Last Updated
November 1, 2022
Sponsor
University College, London
1. Study Identification
Unique Protocol Identification Number
NCT03284775
Brief Title
Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
Official Title
Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 7, 2019 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pituitary Adenoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Intraoperative ultrasound
Intervention Description
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.
Primary Outcome Measure Information:
Title
Technical feasibility
Description
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.
Time Frame
Intraoperative
Title
Device safety
Description
Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction.
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Radiological resection
Description
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.
Time Frame
Early post-operative
Title
Endocrinological remission
Description
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.
Time Frame
Early post-operative
Title
Postoperative complications
Description
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.
Time Frame
Early post-operative
Title
Operating time (minutes)
Time Frame
Intra-operative
Title
Length of stay (days)
Time Frame
Early post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Hospital for Neurology and Neurosurgery
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
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