Pituitary AdenomaNCT03284775
Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma
A study testing Intraoperative ultrasound in people with Pituitary Adenoma, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Intraoperative ultrasound
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Aug 2019to 2 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients
- undergoing transsphenoidal surgery
- diagnosis of pituitary adenoma on pre-operative MRI
- able to provide consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Hospital for Neurology and Neurosurgery
London
About this study
Official title: Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study
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
- Being tested
- Intraoperative ultrasound
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative ultrasoundDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Intraoperative
Secondary outcomes (5)
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.
Measured: Early post-operative
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.
Measured: Early post-operative
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.
Measured: Early post-operative
Operating time (minutes)
Measured: Intra-operative
Length of stay (days)
Measured: Early post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start7 Aug 2019
- Primary completion3 Aug 2022
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284775
- Sponsor's protocol ID
- 17/0310
- Status last verified
- Nov 2023
- First submitted
- 12 Sep 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: a Prospective Devleopment Study
- ClinicalTrials.gov ID
- NCT03284775
- Acronym / sponsor ID
- 17/0310
- Conditions
- Pituitary Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 15 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients
- undergoing transsphenoidal surgery
- diagnosis of pituitary adenoma on pre-operative MRI
- able to provide consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative ultrasoundPatients 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. | Device | – |
Primary outcome
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.
5 secondary outcomes
Radiological resection
Time frame: Early post-operative
Endocrinological remission
Time frame: Early post-operative
Postoperative complications
Time frame: Early post-operative
Operating time (minutes)
Time frame: Intra-operative
Length of stay (days)
Time frame: Early post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative ultrasound in people with Pituitary Adenoma, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical feasibility (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.