Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-07

Study Completion Date

2023-08-02

Brief Summary

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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.

Detailed Description

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Conditions

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Pituitary Adenoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Hospital for Neurology and Neurosurgery

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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17/0310

Identifier Type: -

Identifier Source: org_study_id