Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03284775|
Recruitment Status : Not yet recruiting
First Posted : September 15, 2017
Last Update Posted : October 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pituitary Adenoma||Device: Intraoperative ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study|
|Estimated Study Start Date :||August 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
- 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.
- Technical feasibility [ Time Frame: Intraoperative ]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 [ Time Frame: Intraoperative ]Device safety will be assessed by the number, type, and severity of adverse events related to use of the device e.g., device malfunction.
- Radiological resection [ Time Frame: Early post-operative ]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 [ Time Frame: Early post-operative ]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 [ Time Frame: Early post-operative ]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) [ Time Frame: Intra-operative ]
- Length of stay (days) [ Time Frame: Early post-operative ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284775
|Contact: Hani J Marcus||020 3456 firstname.lastname@example.org|
|Contact: Neil Dorward||020 3456 email@example.com|