Thoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT.

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

This trial tested the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at 3 months post procedure, compared with chest drain insertion and talc slurry.

DESIGN

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

SETTING

This trial was set in 17 NHS hospitals in the UK.

PARTICIPANTS

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

INTERVENTIONS

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

A total of 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 out of 161 (22%) and 38 out of 159 (24%) noted in the poudrage and slurry groups, respectively (odds ratio 0.91, 95% confidence interval 0.54 to 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%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); 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 quality-adjusted life-year gained, poudrage would have a 0.36 probability of being cost-effective compared with slurry.

LIMITATIONS

Entry criteria specified that patients must 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 trial was conducted on an open-label basis, which may have influenced the results of patient-reported measures.

CONCLUSIONS

The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN47845793.

FUNDING

This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 26. See the NIHR Journals Library website for further project information.

Plain language summary

In patients with cancer, fluid can build up in the space between the chest wall and lung, causing breathlessness. The fluid can be drained using a small tube inserted between the ribs under local anaesthetic. However, it often recurs. To avoid this, doctors usually inject talc powder (mixed into a slurry) back down the drainage tube to try to ‘stick’ the lung to the inside of the chest wall. If successful, this prevents the fluid reforming. This procedure is called pleurodesis. An alternative is to insert a camera into the chest under light sedation and local anaesthetic (a ‘thoracoscopy’) and spray talc directly onto the inside of the chest wall (poudrage). This may be more effective, although this has not been proven and it is a slightly more complex procedure. Therefore, this trial was conducted to see if poudrage was more effective than slurry. A total of 330 patients were recruited from 17 UK hospitals who had chest fluid due to cancer. They were divided evenly, with half receiving standard drainage and slurry and the other half receiving a thoracoscopy and poudrage. They were followed up for 6 months. We measured how many experienced a recurrence in fluid build-up 3 months after treatment, as well as other impacts, including if there was any difference in the long-term costs. No difference in clinical effectiveness was found between talc poudrage and talc slurry. Poudrage was unlikely to be cost-effective. In summary, the researchers conclude that slurry is likely to be the preferable method.

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