ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000637448

Ethics application status

Approved

Date submitted

4/12/2007

Date registered

13/12/2007

Date last updated

15/09/2020

Date data sharing statement initially provided

15/09/2020

Date results provided

15/09/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Epidural use and cancer recurrence

Scientific title

Perioperative Epidural Analgesia and Incidence of Late Cancer Recurrence. A follow-up study of patients with cancer who were previously enrolled in the MASTER Trial (1995-2001)

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cancer surgery

Condition category

Condition code

Anaesthesiology

Anaesthetics

Cancer

Biliary tree (gall bladder and bile duct)

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Follow-up of patients enrolled in MASTER Trial - Epidural v control analgesia for cancer surgery. General anaesthesia and epidural drugs and doses were given at the discretion of the anaesthetist during surgery for excision of cancer.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Epidural block for surgery

Control group

Active

Outcomes

Primary outcome [1]

Recurrence-free survival

Timepoint [1]

7-13 years postoperatively

Secondary outcome [1]

All cause mortality

Timepoint [1]

7-13 years postoperatively

Eligibility

Key inclusion criteria

Patients previously enrolled in MASTER Trial 1995-2001. ASA III-IV patients (American Society of Anesthesiology physical status classification) having major abdominal surgery.

Minimum age

No limit

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Patients not enrolled in MASTER Trial. Patients were excluded if they were inelligible for epidural anaesthesia due to sepsis, impaired coagulation status, infection at epidural puncture site, non-vascular disorder or impaired mental state.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Telephone randomisation (in blocks)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Computer randomisation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/02/2008

Actual

2/05/2008

Date of last participant enrolment

Anticipated

Actual

18/06/2010

Date of last data collection

Anticipated

Actual

2/08/2010

Sample size

Target

600

Accrual to date

Final

503

Recruitment in Australia

Recruitment state(s)

ACT,NSW,SA,TAS,WA,VIC

Recruitment postcode(s) [1]

3004

Recruitment outside Australia

Country [1]

Hong Kong

State/province [1]

Country [2]

Malaysia

State/province [2]

Country [3]

Thailand

State/province [3]

Country [4]

Singapore

State/province [4]

Country [5]

Saudi Arabia

State/province [5]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Alfred Hospital

Address [1]

Commercial Road
Melbourne VIC 3004

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Paul Myles

Address

Dept Anaesthesia and Perioperative Medicine
The Alfred Hospital
Commercial Road
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Professor Konrad Jamrozik

Address [1]

Level 2 Public Health Building School of Population Health
University of Queensland
Herston Road
Herston QLD 4006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Helath research and ethics committee

Ethics committee address [1]

Commercial road Melbourne, 3004 vic

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/01/2008

Approval date [1]

04/03/2008

Ethics approval number [1]

10/08

Summary

Brief summary

We plan to undertake an observational "follow-up" study of The MASTER Trial (Alfred EC approval 98/94).  
The MASTER Trial was conducted between 1995 and 2001.  The study consisted of 915 high-risk patients (ASA III-IV) having major abdominal surgery.  Many of these patients underwent cancer surgery.  Half of the patients in The MASTER Trial received epidural analgesia.  We aim to identify whether epidural analgesia protects the immune system during and early after surgery and thus reduces later cancer recurrence.   
Those We intend to follow uo all MASTER Trial patients who had surgery for cancer will be followed up to determine if their cancer has returned and when it returned.  See attached Telephone interview and Protocol 4.
AThere are no new interventions and all patients have previously provided informed consent to the original study but this did not include contact for future research.   The study does not require any new interventions and will involve involve looking through the histories of patients enrolled in The MASTER Trial to determine whether their original surgery was for excision of cancer, therefore making them eligible for inclusion in this follow-up study.  
All eligible patients will then be screened by the Victorian Cancer Council’s (VCC) Database to identify patients who are no longer living.  The VCC Database will also provide valuable information regarding cause of death. Information regarding deceased patients will prevent researchers from attempting to contact next of kin and causing unnecessary distress.  
All patients not listed as having died will be contacted by phone and asked to answer a brief questionnaire regarding their health.and also ringing some patients up.   Patients who cannot be contacted by phone after 3 attempts will be sent a questionnaire.  Researchers will approach GPs and / or next of kin of patients who we are unable to contact.  In the event that researchers are unable to contact patients, GPs or next-of-kin, we will attempt to follow-up patients using a national death index, the Western Australian cancer registry and medical records.
The primary endpoints are the recurrence of cancer within 5 years of initial surgery, and cancer-related deaths.
Secondary endpoints are the type of cancer recurrence: local, regional or distal, and survival.
Researchers will undertake a feasibility study of the Alfred’s 180 patients over an estimated 6 months, prior to following up patients at other centres.

Trial website

Trial related presentations / publications

Myles PS, Peyton M, Silbert BS, Hunt J, Rigg JRA. Sessler DI.  Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: a randomised trial.  BMJ  2011; 342:d1491.

Public notes

Contacts

Principal investigator

Name

Prof Paul Myles

Address

Director, Dept of Anaesthesiology and Perioperative Medicine
Alfred Hospital and Monash University, Melbourne, vic, 3004

Country

Australia

Phone

+61 390762000

Fax

+61 390768176

p.myles@alfred.org.au

Contact person for public queries

Name

Professor Paul Myles

Address

Director
Department of Anaesthesia and Perioperative Medicine
Alfred Hospital and Monash University
Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 90763176

Fax

p.myles@alfred.org.au

Contact person for scientific queries

Name

Professor Paul Myles

Address

Director
Department of Anaesthesia and Perioperative Medicine
Alfred Hospital and Monash University
Commercial Road
Melbourne VIC 3004

Country

Australia

Phone

+61 3 90763176

Fax

p.myles@alfred.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

Source	Title	Year of Publication	DOI
Dimensions AI	Perioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial	2011	https://doi.org/10.1136/bmj.d1491

N.B. These documents automatically identified may not have been verified by the study sponsor.

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