Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

NCT03284775 | Completed

• 1 other identifier: 17/0310
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Radiological resection

  Early post-operative

• Endocrinological remission

  Early post-operative

• Postoperative complications

  Early post-operative

• Operating time (minutes)

  Intra-operative

• Length of stay (days)

  Early post-operative

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• undergoing transsphenoidal surgery
• diagnosis of pituitary adenoma on pre-operative MRI
• able to provide consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

National Hospital for Neurology and Neurosurgery

London, United Kingdom

Location

MeSH Terms

Conditions

Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 15, 2017
• Study Start: August 7, 2019
• Primary Completion: August 3, 2022
• Study Completion: August 2, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)