ANZCTR - Registration

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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]

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

Hormone Deficiencies

Condition category

Condition code

Neurological

Other neurological disorders

Metabolic and Endocrine

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]

Not applicable

Comparator / control treatment

No camparator or control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

6 months post surgery

Secondary outcome [1]

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]

Measured at the time of surgery

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment hospital [2]

St Vincent's Private Hospital - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

St Vincent's Hospital, Melbourne

Address [1]

35 Victoria Parade
Fitzroy, 3065,
Victoria

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

St Vincents Hospital Research and Ethics

Ethics committee address [1]

St Vincent's hospital Melbourne
35 Victoria Parade, Fitzroy, 3065
Melbourne, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/10/2012

Approval date [1]

26/11/2012

Ethics approval number [1]

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

Dr Carmela Caputo

Address

St Vincent's Hospital Melbourne,
4th Floor Daly Wing
Department Endocrinology and Diabetes
35 Victoria Parade,
Fitzroy 3065

Country

Australia

Phone

+61 3 9288 2211

Fax

carmela.caputo@svha.org.au

Contact person for public queries

Name

Carmela Caputo

Address

4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Victoria

Country

Australia

Phone

+61 3 9288 3579

Fax

+61 3 9288 3590

carmela.caputo@svhm.org.au

Contact person for scientific queries

Name

Carmela Caputo

Address

4th Floor Daly Wing
Department of Endocrinology
St Vincent's Hospital,
35 Victoria Parade, Fitzroy, 3065
Victoria

Country

Australia

Phone

+61 3 9288 3579

Fax

+61 3 9288 3590

carmela.caputo@svha.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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