A randomised trial (TAPPS) comparing thoracoscopy and talc poudrage under local anaesthesia, with intercostal drainage and talc slurry infusion, to treat malignant pleural effusion

Rahul Bhatnagar, Ramon Luengo-Fernandez, Brennan C Kahan, Najib M Rahman, Robert F Miller, Nick A Maskell

Research output: Contribution to journalArticle (Academic Journal)

Abstract

Background
There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective.

Objective(s)
To test the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at three months post-procedure, compared to chest drain insertion and talc slurry.

Design
A multicentre, open-label, randomised controlled trial with embedded economic evaluation. Follow-up took place at 1, 3 and 6 months

Setting
Seventeen NHS hospitals in the UK

Participants
330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis, and fit to undergo thoracoscopy under local anaesthetic. Those needing a tissue diagnosis or with evidence of lung entrapment were excluded.

Allocation and interventions
Allocation took place following minimisation with a random component, performed by a web-based, centralised computer system. Patients in the control arm were treated with bedside chest drain insertion and 4g talc slurry. In the intervention arm, patients underwent local anaesthetic thoracoscopy with 4g talc poudrage.

Main outcome measures
The primary outcome measure was pleurodesis failure at 90 days post randomisation. Secondary outcome measures included mortality and patient-reported symptoms. A cost-utility analysis was also performed.

Results
166 and 164 patients were allocated to poudrage and slurry respectively. Participants were well-matched at baseline. For the primary outcome, no significant difference in pleurodesis failure was observed between the treatment groups at 90 days, with rates of 36/161 (22%) and 38/159 (24%) noted in the poudrage and slurry groups respectively (odds ratio (OR) 0.91, 95% confidence interval (CI) 0.54-1.55, p=0.74). No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days (poudrage 46/161 (29%), slurry 44/159 (28%), OR 1.05, 95% CI 0.63-1.73, p=0.86); mean (standard deviation) number of nights in hospital over 90 days (poudrage 12 (13), slurry 11 (10), p=0.35); and all-cause mortality at 180 days (poudrage 66/166 (40%), slurry 68/164 (42%), p=0.70). At £20,000 per QALY gained, poudrage would have a 0.36 probability of being cost-effective compared to slurry.

Limitations
Entry criteria specified that patients be sufficiently fit to undergo thoracoscopy, which may make the results less applicable to those patients presenting with a greater degree of frailty. Furthermore, the study was conducted on an open-label basis, which may have influenced the results of patient-reported measures.

Conclusions
TAPPS has robustly demonstrated that there is no additional clinical or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of MPE.

Study registration
The trial is registered at ISRCTN47845793
Original languageEnglish
JournalNIHR Journals Library
Publication statusAccepted/In press - 11 Jun 2020

Keywords

  • malignant pleural effusion
  • thoracoscopy
  • chest drain
  • talc slurry
  • talc poudrage
  • pleurodesis
  • cost-effectiveness
  • randomised controlled trial

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