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Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

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ClinicalTrials.gov Identifier: NCT03284775
Recruitment Status : Not yet recruiting
First Posted : September 15, 2017
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
University College, London

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Operating time (minutes) [ Time Frame: Intra-operative ]
  5. Length of stay (days) [ Time Frame: Early post-operative ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03284775


Contacts
Contact: Hani J Marcus 020 3456 7890 hani.marcus@uclh.nhs.uk
Contact: Neil Dorward 020 3456 7890 neil.dorward@uclh.nhs.uk

Sponsors and Collaborators
University College, London

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03284775     History of Changes
Other Study ID Numbers: 17/0310
First Posted: September 15, 2017    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pituitary Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Brain Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Adenoma
Pituitary Diseases
Hypothalamic Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases