Trial Review

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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 information initially 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] 302317 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer surgery 2601 0
Condition category
Condition code
Anaesthesiology 2714 2714 0 0
Anaesthetics
Cancer 2738 2738 0 0
Biliary tree (gall bladder and bile duct)
Anaesthesiology 2739 2739 0 0
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] 2359 0
Treatment: Other
Comparator / control treatment
Epidural block for surgery
Control group
Active

Outcomes
Primary outcome [1] 3610 0
Recurrence-free survival
Timepoint [1] 3610 0
7-13 years postoperatively
Secondary outcome [1] 6051 0
All cause mortality
Timepoint [1] 6051 0
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?
No
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] 512 0
3004
Recruitment outside Australia
Country [1] 702 0
Hong Kong
State/province [1] 702 0
Country [2] 703 0
Malaysia
State/province [2] 703 0
Country [3] 704 0
Thailand
State/province [3] 704 0
Country [4] 705 0
Singapore
State/province [4] 705 0
Country [5] 706 0
Saudi Arabia
State/province [5] 706 0

Funding & Sponsors
Funding source category [1] 2853 0
Hospital
Name [1] 2853 0
The Alfred Hospital
Country [1] 2853 0
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] 2571 0
Individual
Name [1] 2571 0
Professor Konrad Jamrozik
Address [1] 2571 0
Level 2 Public Health Building School of Population Health
University of Queensland
Herston Road
Herston QLD 4006
Country [1] 2571 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306915 0
Alfred Helath research and ethics committee
Ethics committee address [1] 306915 0
Commercial road Melbourne, 3004 vic
Ethics committee country [1] 306915 0
Australia
Date submitted for ethics approval [1] 306915 0
17/01/2008
Approval date [1] 306915 0
04/03/2008
Ethics approval number [1] 306915 0
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 28224 0
Prof Paul Myles
Address 28224 0
Director, Dept of Anaesthesiology and Perioperative Medicine
Alfred Hospital and Monash University, Melbourne, vic, 3004
Country 28224 0
Australia
Phone 28224 0
+61 390762000
Fax 28224 0
+61 390768176
Email 28224 0
[email protected]
Contact person for public queries
Name 11381 0
Prof Professor Paul Myles
Address 11381 0
Director
Department of Anaesthesia and Perioperative Medicine
Alfred Hospital and Monash University
Commercial Road
Melbourne VIC 3004
Country 11381 0
Australia
Phone 11381 0
+61 3 90763176
Fax 11381 0
Email 11381 0
[email protected]
Contact person for scientific queries
Name 2309 0
Prof Professor Paul Myles
Address 2309 0
Director
Department of Anaesthesia and Perioperative Medicine
Alfred Hospital and Monash University
Commercial Road
Melbourne VIC 3004
Country 2309 0
Australia
Phone 2309 0
+61 3 90763176
Fax 2309 0
Email 2309 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Myles PS, Peyton M, Silbert BS, Hunt J, Rigg JRA. ... [More Details]
Plain language summaryNo Long term follow-up data were available for 94% (... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIPerioperative epidural analgesia for major abdominal surgery for cancer and recurrence-free survival: randomised trial2011https://doi.org/10.1136/bmj.d1491
N.B. These documents automatically identified may not have been verified by the study sponsor.