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Trial registered on ANZCTR


Registration number
ACTRN12611000567921
Ethics application status
Approved
Date submitted
20/05/2011
Date registered
2/06/2011
Date last updated
10/08/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A Multicentre Randomized Study Comparing
Indwelling Pleural Catheter vs Talc Pleurodesis in Patients with a Malignant Pleural Effusion
Scientific title
A Multicentre Randomized Study Comparing Days in Hospital with Indwelling Pleural Catheter vs Talc Pleurodesis in Patients with a Malignant Pleural Effusion
Secondary ID [1] 262216 0
Nil
Universal Trial Number (UTN)
Trial acronym
AMPLE (Australasian Malignant PLeural Effusion trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Pleural Effusion 267906 0
Condition category
Condition code
Cancer 268054 268054 0 0
Any cancer
Respiratory 268053 268053 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indwelling Pleural Catheter (IPC):

A soft flexible silicon catheter placed in the pleural space and tunnelled through the subcutaneous tissues. It is anchored by a cuff in the subcutaneous segment into which fibroblasts grow.

IPCs are inserted under light sedation and local anaesthesia, often in a Day Procedure Unit being discharged home after just a few hours. They allow simple, painless ambulatory drainage of effusions, averting hospital attendances.

They are designed to remain in situ for the remainder of the patient's life, but around 40% of patients are able to have the IPC removed because of spontaneous pleurodesis (a benefit of the IPC treatment keeping the pleural space dry).
Intervention code [1] 264612 0
Treatment: Devices
Comparator / control treatment
Talc Pleurodesis:

Talc pleurodesis is the conventional treatment of malignant pleural effusions and involves iatrogenic induction of pleural fibrosis to obliterate the pleural cavity. It is an inpatient procedure performed at the bedside by inserting a small bore chest drain (<16 Fr), draining the fluid to dryness and (if the lung reexpands) injecting talc slurry into the pleural space.

If the lung reexpands pleurodesis has a 60-80% chance of successfully preventing the need for further pleural drainage.

If the lung does not reexpand to the point where >75% of the visceral and parietal pleura are touching on chest radiograph (trapped lung), then 10-20cm H2O suction will applied until this occurs, or if this fails then talc will not be administered and the patient will be offered other treatments (including IPC) by their treating physician.

Pleurodesis will be deemed to have failed if fluid recurs and the patient is symptomatic enough to warrant further drainage procedures. In this event, further treatments (simple drainage, repeat pleurodesis, IPC) will be chosen by the patient and their treating physician.

All patient outcomes will be analysed on an intention to treat basis.
Control group
Active

Outcomes
Primary outcome [1] 266797 0
Number of days spent in hospital (bed days):

This includes all hospital admissions following intervention, until death or the end of the study (1 year). The primary endpoint is chosen as it the most meaningful outcome for cancer patients and their clinicians.

The patients will be asked at each follow up whether they have spent any time in hospital in the intervening period. Their medical records (both electronic admissions data and written records) will also be reviewed at every follow up, and the number of days will be counted at each vist and stored in the confidential database.

Given the impossibility of blinding, hospital admissions will be decided by the independent treating physicians, not by the investigators wherever possible. The reason(s) for admission must be documented and satisfy at least one of the following criteria:

-Any procedure required that cannot be performed in the outpatient setting because of the need for >4 hours of close nursing or medical attention.

-A coexisting or new medical problem requires inpatient therapy.

-Cancer or effusion-related symptoms that cannot be adequately controlled at home with community nursing and GP support.

Incomplete days, eg day procedure admission for IPC-insertion, will be rounded up to 1. Day-case chemotherapy administration will not be included as admissions. The validity of all investigator-initiated admissions will be independently assessed by a preapproved assessor within one month of the event occurring.
Timepoint [1] 266797 0
All follow up appointments until death or 1 year.
Secondary outcome [1] 276408 0
Health cost assessment:

direct clinical costs from WA Health Dept coding data and other estimated community-based costs will be captured from patient diary records.
Timepoint [1] 276408 0
At the end of the study
Secondary outcome [2] 276403 0
Quality of Life:

This will be assessed by visual analogue score (VAS) immediately prior to and daily for 1 week after any pleural procedure/intervention, and at every follow up subsequently.
Timepoint [2] 276403 0
Follow up is fortnightly for 2 months then monthly to 1 year
Secondary outcome [3] 276404 0
Breathlessness:

VAS. As above
Timepoint [3] 276404 0
Fortnightly for 2 months then monthly to 1 year

Eligibility
Key inclusion criteria
Symptomatic Malignant Pleural Effusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <18 years; an effusion <2cm at maximum depth; expected survival <3 months; chylothorax; previous ipsilateral lobectomy or pneumonectomy; previous attempted pleurodesis; pleural infection; leukocytopenia (<1.0x109/L); pregnant or lactating patients; uncorrectable bleeding diathesis; inability to give informed consent or comply with the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients with Malignant Pleural Effusions (MPE) presenting to participating centres, who meet the inclusion criteria and not exclusion criteria, will be offered entry to the study.

When informed consent to participate is obtained patients will be randomly assigned (1:1) to either an IPC or talc pleurodesis for their malignant pleural effusion. This randomisation will be performed off site by an independent statistician. The allocation will not be concealed form either the investigator, the treating physician or the patient, as it is impossible to hide which procedure is being employed.

(IPC - a tube is tunneled and left in place and the patient is discharged; or Pleurodesis - the patient is admitted, a simple chest drain is inserted, and talc is then infiltrated before removing the tube).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A statistician, not involved in the trial, will manage the allocation sequence. Computer-derived allocation will be delivered and randomization will include minimization for
1) histological type (mesothelioma vs non-mesothelioma) as median survival is longer in mesothelioma (12 vs 4 months), and the risk of catheter-track metastases may be higher with mesothelioma; and
2) the presence of trapped lung, as this has been postulated to reduce the likelihood of a successful pleurodesis.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/06/2012
Actual
2/07/2012
Date of last participant enrolment
Anticipated
Actual
16/10/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
146
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 4162 0
The Sutherland Hospital - Caringbah
Recruitment hospital [2] 4156 0
Swan Districts Hospital - Middle Swan
Recruitment hospital [3] 4155 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [4] 4163 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [5] 4161 0
St George Hospital - Kogarah
Recruitment hospital [6] 4160 0
Nambour General Hospital - Nambour
Recruitment hospital [7] 4157 0
Fremantle Hospital and Health Service - Fremantle
Recruitment hospital [8] 4158 0
St John of God Hospital, Bunbury - Bunbury
Recruitment hospital [9] 4159 0
Holy Spirit Northside - Chermside
Recruitment outside Australia
Country [1] 7088 0
Hong Kong
State/province [1] 7088 0
Country [2] 3596 0
New Zealand
State/province [2] 3596 0
Wellington
Country [3] 7087 0
Singapore
State/province [3] 7087 0

Funding & Sponsors
Funding source category [1] 267144 0
Charities/Societies/Foundations
Name [1] 267144 0
Cancer Council of Western Australia
Country [1] 267144 0
Australia
Funding source category [2] 267112 0
Hospital
Name [2] 267112 0
Dust Diseases Board
Country [2] 267112 0
Australia
Primary sponsor type
Individual
Name
Prof YC Gary Lee
Address
School of Medicine and Pharmacology
4th Floor G Block
Sir Charles Gairdner Hospital
Nedlands
Perth
WA 6009
Country
Australia
Secondary sponsor category [1] 264191 0
Hospital
Name [1] 264191 0
Sir Charles Gairdner Hospital
Address [1] 264191 0
Hospital Avenue
Nedlands
Perth
WA 6009
Country [1] 264191 0
Australia
Other collaborator category [1] 252010 0
Individual
Name [1] 252010 0
Prof Grant Waterer
Address [1] 252010 0
University of Western Australia
Royal Perth Hospital
Wellington St
Perth
WA 6001
Country [1] 252010 0
Australia
Other collaborator category [2] 252009 0
Individual
Name [2] 252009 0
Dr Edward T.H. Fysh
Address [2] 252009 0
Respiratory Medicine
B Block,
Sir Charles Gairdner Hospital
Nedlands
Perth
WA 6009
Country [2] 252009 0
Australia
Other collaborator category [3] 252011 0
Individual
Name [3] 252011 0
Prof Peter Kendall
Address [3] 252011 0
Head Respiratory Department
Fremantle Hospital
Alma St
Fremantle
WA 6959
Country [3] 252011 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267090 0
Sir Charles Gairdner Group Human Research and Ethics Committee
Ethics committee address [1] 267090 0
Ethics committee country [1] 267090 0
Australia
Date submitted for ethics approval [1] 267090 0
31/01/2012
Approval date [1] 267090 0
19/04/2012
Ethics approval number [1] 267090 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32635 0
Prof YC Gary Lee
Address 32635 0
B Block
Respiratory Department
Hospital Avenue
Sir Charles Gairdner Hospital
Nedlands
WA 6009
Country 32635 0
Australia
Phone 32635 0
+61 8 61510892
Fax 32635 0
Email 32635 0
gary.lee@uwa.edu.au
Contact person for public queries
Name 15882 0
Prof YC Gary Lee
Address 15882 0
University of Western Australia
School of Medicine and Pharmacology
4th Floor G Block
Sir Charles Gairdner Hospital
Hospital Ave
Nedlands
Perth
WA 6009
Country 15882 0
Australia
Phone 15882 0
+61893464968
Fax 15882 0
Email 15882 0
gary.lee@uwa.edu.au
Contact person for scientific queries
Name 6810 0
Gary Lee
Address 6810 0
B Block
Respiratory Department
Hospital Avenue
Sir Charles Gairdner Hospital
Nedlands
WA 6009
Country 6810 0
Australia
Phone 6810 0
+61893464968
Fax 6810 0
Email 6810 0
gary.lee@uwa.edu.au

No information has been provided regarding IPD availability


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 November 2017 https://jamanetwork.com/journals/... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIProtocol of the Australasian Malignant Pleural Effusion (AMPLE) trial: a multicentre randomised study comparing indwelling pleural catheter versus talc pleurodesis2014https://doi.org/10.1136/bmjopen-2014-006757
EmbaseEffect of an indwelling pleural catheter vs talc pleurodesis on hospitalization days in patients with malignant pleural effusion: The AMPLE randomized clinical trial.2017https://dx.doi.org/10.1001/jama.2017.17426
N.B. These documents automatically identified may not have been verified by the study sponsor.