Plain English Summary
http://www.cancerresearchuk.org/cancer-help/trials/a-trial-looking-at-how-treat-fluid-lung-tapps
Trial website
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
Dr Rahul Bhatnagar
ORCID ID
Contact details
-
-
-
United Kingdom
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 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 trial start date
15/07/2012
Overall trial end date
31/10/2018
Reason abandoned (if study stopped)
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
24/10/2017
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
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
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25428632
2014 strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25416527