A randomised trial to determine the best method for delivering talc for the management of malignant pleural effusions in patients with a good performance status

ISRCTN	ISRCTN47845793
DOI	https://doi.org/10.1186/ISRCTN47845793
Secondary identifying numbers	HTA 10/50/42, 2843, UKCRN:12537

Submission date: 24/05/2012
Registration date: 28/05/2012
Last edited: 06/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-how-treat-fluid-lung-tapps

Contact information

Dr Nick Maskell
Scientific

Respiratory Research Unit
Southmead Hospital
Bristol
BS10 5NB
United Kingdom

Email	nick.maskell@nbt.nhs.uk

Dr Rahul Bhatnagar
Scientific

-
-
-
United Kingdom

Study information

Study design	Randomised open-label multi-centre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	TAPPS
Study objectives	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(s)	NRES Committee North West – Preston, 26/06/2012, ref: 12/NW/0467
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	15/07/2012
Completion date	31/10/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	330
Total final enrolment	330
Key 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
Key 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
Date of first enrolment	01/08/2012
Date of final enrolment	24/10/2017

Locations

Countries of recruitment

England
Scotland
United Kingdom

Study participating centres

Southmead Hospital

Monks Park Avenue
Bristol
BS10 5NB
United Kingdom

Nottingham City Hospital

Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Musgrove Park Hospital

Taunton
TA1 5DA
United Kingdom

Churchill Hospital

Headington
Oxford
OX3 7LE
United Kingdom

Medway Maritime Hospital

Gillingham
ME7 5NY
United Kingdom

King’s Mill Hospital

Mansfield Road
Sutton in Ashfield
Nottingham
NG17 4JL
United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Fulwood
Preston
PR2 9HT
United Kingdom

Wythenshawe Hospital

Southmoor Road
Wythenshawe
Manchester
M23 9LT
United Kingdom

Addenbrooke’s Hospital

Hills Road
Cambridge
CB2 0QQ
United Kingdom

St Thomas’ Hospital

Westminster Bridge Road
London
SE1 7EH
United Kingdom

Doncaster Royal Infirmary

Armthorpe Road
Doncaster
DN2 5LT
United Kingdom

University Hospital of North Tees

Hardwick
Stockton
TS19 8PE
United Kingdom

Aintree University Hospital

Liverpool
L9 7AL
United Kingdom

Southern General Hospital

1345 Govan Road
Glasgow
G51 4TF
United Kingdom

Milton Keynes Hospital NHS Foundation Trust

Standing Way
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom

Queen Elizabeth Hospital

Birmingham
B15 2TH
United Kingdom

Sponsor information

North Bristol NHS Trust (UK)
Not defined

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

"ROR"	https://ror.org/036x6gt55

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
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.
IPD sharing plan	The trial was funded by the NIHR HTA programme, who will publish the full data and a comprehensive study report at the same time as the academic manuscript. This will be open access and thus available to anyone in perpetuity. For further information email the study Chief Investigator, Nick Maskell, at nick.maskell@bristol.ac.uk. Consent was obtained and all data are anonymised.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Other publications	strategies	21/11/2014		Yes	No
Protocol article	protocol	26/11/2014		Yes	No
Results article	results	05/12/2019	06/12/2019	Yes	No

Editorial Notes

06/12/2019: Publication reference added.
22/10/2019: The total final enrolment number and IPD sharing statement were added.
15/01/2018: The recruitment end date was changed from 01/06/2016 to 24/10/2017. The overall trial end date was changed from 31/01/2017 to 31/10/2018.