Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000991819
Ethics application status
Approved
Date submitted
11/09/2012
Date registered
14/09/2012
Date last updated
22/06/2021
Date data sharing statement initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Patients with non-functioning pituitary tumours: Are there differences between gender in post-operative hormone outcomes and does this relate to the pressure within the tumours?
Scientific title
Participants with non-functioning pituitary macroadenomas: Intrasellar pressure measurement at the time of operation and pituitary hormone deficiencies. Do gender differences exist?
Secondary ID [1] 281215 0
Nil
Universal Trial Number (UTN)
U1111-1134-5769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non functioning pituitary adenomas 287405 0
Hormone Deficiencies 287406 0
Condition category
Condition code
Neurological 287733 287733 0 0
Other neurological disorders
Metabolic and Endocrine 287734 287734 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1) Observational data of hormone deficiencies pre and 6 months post operatively for surgically treated non functioning pituitary adenomas.
2) Measurement of pressure within the pituitary adenoma at the time of surgery
3) Quality of life questionnaire pre and 6 months post surgery
Intervention code [1] 285682 0
Not applicable
Comparator / control treatment
No camparator or control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287973 0
That Premenopausal females have fewer hormone deficiencies compared to males and postmenopausal females post-operatively for treatment of non functioning pituitary macroadenomas. This will be assessed by the collection of biochemical hormone blood test. The hormonal assessment is routine part of clinical management of this condition. We aim to collect this data.
Timepoint [1] 287973 0
6 months post surgery
Secondary outcome [1] 299164 0
That Intrasellar pressure measured at the time of operation is lower in premenopausal females compared to males and postmenopausal females. This measurement of intrasellar pressure will be measured at the time of surgery using a commercial kit - Codman Intracranial Pressure Monitoring Kit (Camino Laboratories San Diego CA). At surgery, dura is exposed by removal of the bony sella floor, and a 1.5mm dural opening made allowing insertion of the fiberoptic transducer tip into the pituitary tumour with minimal chance of tumour extravasation. When a stable waveform is present on the pressure monitor, mean ISP is recorded and the catheter removed, with surgery proceeding as usual. This procedure will take 3-5 minutes.
Timepoint [1] 299164 0
Measured at the time of surgery
Secondary outcome [2] 299190 0
The measurement of Quality of life of participants pre and 6 month post surgery: that quality of life remains unchanged. This will be undertaken by a a validated questionnaire SF36- 4 week recall. Participants will undertake the questionnaire pre-operatively and 6 months post-peratively, with each participant acting as their own control
Timepoint [2] 299190 0
Pre-operatively and 6 months post-operatively

Eligibility
Key inclusion criteria
All adult patients who require surgery for non functioning pituitary adenomas having surgery at the study hospitals will be eligible for inclusion in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give consent

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2013
Actual
7/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
73
Accrual to date
45
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19785 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 19786 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 34431 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 285993 0
Hospital
Name [1] 285993 0
St Vincent's Hospital, Melbourne
Country [1] 285993 0
Australia
Primary sponsor type
Individual
Name
Carmela Caputo
Address
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Victoria
Country
Australia
Secondary sponsor category [1] 284812 0
None
Name [1] 284812 0
Address [1] 284812 0
Country [1] 284812 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288040 0
St Vincents Hospital Research and Ethics
Ethics committee address [1] 288040 0
St Vincent's hospital Melbourne
35 Victoria Parade, Fitzroy, 3065
Melbourne, Australia
Ethics committee country [1] 288040 0
Australia
Date submitted for ethics approval [1] 288040 0
01/10/2012
Approval date [1] 288040 0
26/11/2012
Ethics approval number [1] 288040 0
HREC-A 028/12

Summary
Brief summary
The pituitary gland is an important gland that assists in control and release of hormones in the body. Abnormal growths in the gland, called “pituitary tumours or adenomas” can occur. The most frequent type requiring surgery is the non-functioning pituitary macroadenoma (NFPMA), which are tumours that don’t produce any excessive hormones but can be associated with hormone deficiences.
At St Vincent’s Hospital, we have reviewed our own historical series of NFPMA. Between 1995 and 2010, 141 cases of NFPMA were operated on. It was observed that males were more likely than females to be to have 2 or more hormonal deficiencies at presentation. Post-operatively, 2 or more hormone deficiencies occurred more frequently in males and postmenopausal females but rarely in premenopausal females. So it appears that premenopausal females to have better hormonal outcomes.
We have hypothesed that it may be related to lower pressure within tumours of premenopausal females. High pressure in the tumour is postulated to reduce blood flow to the pituitary gland and leads to death of normal hormone producing cells, thus less ability for hormonal recovery.
This current project has been designed to confirm if gender differences in hormone deficiencies do occur after surgery. Also to demonstrate that pressure within tumours of premenopausal females in lower than males and postmenopausal females.
These findings are important as they contribute to the understanding of hormonal differences in genders, which has not been fully examined before.
Trial website
Trial related presentations / publications
Clin Endocrinol (Oxf). 2012 Aug 13. doi: 10.1111/cen.12009. [Epub ahead of print]

Gender differences in presentation and outcome of non-functioning pituitary macroadenomas.

Caputo C, Sutherland T, Farish S, McNeill P, Ng KW, Inder WJ.
Public notes

Contacts
Principal investigator
Name 34702 0
Dr Carmela Caputo
Address 34702 0
St Vincent's Hospital Melbourne,
4th Floor Daly Wing
Department Endocrinology and Diabetes
35 Victoria Parade,
Fitzroy 3065
Country 34702 0
Australia
Phone 34702 0
+61 3 9288 2211
Fax 34702 0
Email 34702 0
[email protected]
Contact person for public queries
Name 17949 0
Dr Carmela Caputo
Address 17949 0
4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Victoria
Country 17949 0
Australia
Phone 17949 0
+61 3 9288 3579
Fax 17949 0
+61 3 9288 3590
Email 17949 0
[email protected]
Contact person for scientific queries
Name 8877 0
Dr Carmela Caputo
Address 8877 0
4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Victoria
Country 8877 0
Australia
Phone 8877 0
+61 3 9288 3579
Fax 8877 0
+61 3 9288 3590
Email 8877 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.