Condition category
Cancer
Date applied
24/05/2012
Date assigned
28/05/2012
Last edited
04/08/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Nick Maskell

ORCID ID

Contact details

Respiratory Research Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
-
nick.maskell@nbt.nhs.uk

Type

Scientific

Additional contact

Ms Hania Piotrowska

ORCID ID

Contact details

Oxford Respiratory Trials Unit
Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom
-
hania.piotrowska@ouh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 10/50/42, 2843, UKCRN:12537

Study information

Scientific title

Evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry: A randomised, open-label trial to determine the most effective method for the management of malignant pleural effusions in patients with a good performance status

Acronym

TAPPS

Study hypothesis

Primary research question:
Does thoracoscopy and talc poudrage increase the proportion of patients with successful pleurodesis at three months post-procedure, when compared to standard therapy with chest drain insertion and talc slurry instillation?

Secondary research questions:
1. Does thoracoscopy and talc poudrage reduce the time to pleurodesis failure, measured at three and six months post-procedure, when compared to standard therapy with chest drain insertion and talc slurry instillation?
2. Does fluid drainage and talc poudrage at thoracoscopy improve chest x-ray appearances at 24 hours and at 3 months post-procedure, when compared to standard fluid drainage via chest tube alone?
3. Does thoracoscopy and talc poudrage cause less breathlessness and thoracic pain for the first five days post-procedure, when compared to standard therapy with chest drain insertion and talc slurry instillation?
4. Does thoracoscopy and talc poudrage improve health-related quality of life over the six months post-procedure, when compared to standard therapy with chest drain insertion and talc slurry instillation?
5. Is thoracoscopy and talc poudrage cost effective over six months, when compared to standard therapy with chest drain insertion and talc slurry instillation?
6. Does thoracoscopy and talc poudrage reduce healthcare utilisation during the six months post-procedure, when compared to standard therapy with chest drain insertion and talc slurry instillation?

On 07/01/2015 the overall trial end date was changed from 15/01/2015 to 31/01/2017.

Ethics approval

NRES Committee North West – Preston, 26/06/2012, ref: 12/NW/0467

Study design

Randomised open-label multi-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Malignant pleural effusion

Intervention

1. Small-bore chest drain insertion followed by 4 g graded sterile talc slurry pleurodesis
2. Medical (local anaesthetic) thoracoscopy followed by 4 g graded sterile talc poudrage

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Number of patients who experience pleurodesis failure up to three months (90 days) post randomisation

Secondary outcome measures

1. Requirement for further pleural procedures up to 6 months post-randomisation, as assessed by two independent, blinded adjudicators. The adjudicator will be provided with relevant radiological images and information regarding the patient's health status, including performance status and Visual Analogue Scores (VAS) scores for breathlessness and thoracic pain
2. Percentage radiographic (chest x-ray) pleural opacification, measured by visual estimation in a blinded fashion, on the side of the pleurodesis attempt at 24 hours post poudrage or slurry instillation, and at 3 and 6 months post randomisation
3. Self-reported health-related quality of life, as measured using the SF-36 and EQ-5D questionnaires measured at 1 month, 3 months and 6 months post randomisation
4. Self-reported thoracic pain, as measured using VAS scores recorded daily for the first 7 days post randomisation, and then weekly for the duration of trial follow-up
5. Self-reported breathlessness, as measured using VAS scores recorded daily for the first 7 days post randomisation, and then weekly for the duration of trial follow-up.
6. The number of patients with pleurodesis failure up to one month (30 days) post randomisation
7. The number of patients with pleurodesis failure up to six months (180 days) post randomisation
8. All-cause mortality up to six months (180 days) post-randomisation
9. Time to pleurodesis failure, censored at six months (180 days) post randomisation
10. Time from randomisation to hospital discharge
11. Number of days spent as a hospital inpatient up to three months
12. Healthcare resource usage and costs at six months (180 days) post randomisation
13. The costs of performing talc pleurodesis under the two interventions under study
14. Follow-up costs

Overall trial start date

15/07/2012

Overall trial end date

31/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis, defined as:
1.1. Pleural effusion with histocytologically proven pleural malignancy OR
1.2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
1.3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
2. Fit enough to undergo local anaesthetic thoracoscopy, as per British Thoracic Society (BTS) guidelines
3. Expected survival >3 months
4. Written, informed consent to trial participation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

330

Participant exclusion criteria

1. Patients in whom thoracoscopy is the only reasonable approach to making a diagnosis, and in whom such a diagnosis would significantly influence further management
2. Age < 18 years
3. Females who are pregnant or lactating
4. Evidence of extensive lung entrapment on chest X-ray (CXR) or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis
5. Insufficient volume or position of pleural fluid on lateral decubitus thoracic ultrasound to safely perform local anaesthetic thoracoscopy without further intervention being necessary
6. Previously documented adverse reaction to talc
7. Clear contraindication to thoracoscopy or chest tube insertion

Recruitment start date

01/08/2012

Recruitment end date

01/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southmead Hospital
Monks Park Avenue
Bristol
BS10 5NB
United Kingdom

Trial participating centre

Nottingham City Hospital
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Churchill Hospital
Headington
Oxford
OX3 7LE
United Kingdom

Trial participating centre

Medway Maritime Hospital
Gillingham
ME7 5NY
United Kingdom

Trial participating centre

King’s Mill Hospital
Mansfield Road Sutton in Ashfield
Nottingham
NG17 4JL
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Fulwood
Preston
PR2 9HT
United Kingdom

Trial participating centre

Wythenshawe Hospital
Southmoor Road Wythenshawe
Manchester
M23 9LT
United Kingdom

Trial participating centre

Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

St Thomas’ Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

Trial participating centre

Doncaster Royal Infirmary
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

Trial participating centre

University Hospital of North Tees
Hardwick
Stockton
TS19 8PE
United Kingdom

Trial participating centre

Aintree University Hospital
Liverpool
L9 7AL
United Kingdom

Trial participating centre

Southern General Hospital
1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Trial participating centre

Milton Keynes Hospital NHS Foundation Trust
Standing Way Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

c/o Ms Helen Lewis
Research and Innovation
Floor 3
Learning and Research Building
Southmead Hospital
Bristol
BS105NB
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment (HTA) (UK) (ref. 10/50/42)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The protocol will be published in an open access journal. The full trial results will be published in peer reviewed journals and presented at national and international conferences. Trial results will also be disseminated to appropriate patient groups/charities upon completion.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25428632
2014 strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25416527

Publication citations

Additional files

Editorial Notes