Title: Prospective randomised trial evaluating the efficacy of local anaesthetic thoracoscopy and talc slurry pleurodesis (TAPPS)
Funder: Department of Health and Social Care

Abstract: Malignant pleural effusions (MPE) are a major cause of morbidity amongst cancer patients, usually leading to significant breathlessness. Currently, there are about 250,000 new cases per year in the United States and the UK, which causes a heavy burden on healthcare services. Median survival from diagnosis is typically around 6 months. Management of malignant pleural effusions usually entails attempted pleurodesis. The most proven and widely-used sclerosant is sterile talc, which may be given using one of two methods. The first, more traditional approach is to remove the fluid using a bedside intercostal chest drain and to then instil a talc slurry solution through it. An alternative is to perform a local anaesthetic thoracoscopy before spraying talc powder onto the pleural surfaces (‘poudrage’). Thoracoscopy is becoming more widely available in the UK and is used frequently to perform talc poudrage. Our own audit data has suggested a benefit to using this approach over bedside talc slurry, although the published trials in this area have been few and have suffered from methodological flaws. There are also potential benefits in patients’ quality of life, and costs to healthcare providers in using poudrage, as this procedure usually involves a much shorter hospital stay. The TAPPS trial aims to answer definitively whether there are significant differences in efficacy, safety and cost in using thoracoscopy and talc poudrage over talc slurry pleurodesis for the management of malignant pleural effusions. We aim to recruit 330 patients from across the UK and randomise them to receive either talc poudrage (intervention) or bedside talc slurry (control), and to then compare pleurodesis success rates at three months. This trial has the potential to inform and change current NHS and international practice by determining the most effective approach to managing this difficult group of patients.

Lay abstract: Patients who suffer with cancer (malignancy) can sometimes develop fluid (an effusion) in between the two tissue layers which surround the lung (the pleura). These malignant pleural effusions, or MPE, can be a major cause of disabling symptoms. The simplest method for managing MPE is to insert a chest tube to drain away the fluid. In order to prevent recurrence, an irritant substance such as talc is injected through the chest tube before removal. This can cause the pleura to stick together (pleurodesis), to prevent further fluid build-up, and is successful around 80% of the time. However, this method can be burdensome to patients, who often have to remain in hospital for up to a week. An alternative approach involves a minor procedure called thoracoscopy. A camera is passed in to the pleural space, which allows for a more detailed examination of the pleura and rapid drainage of fluid. If a malignant pleural effusion is suspected, pleurodesis can be attempted by spraying a fine talc powder over the whole of the affected lung. This approach is known as “poudrage.” Thoracoscopy and poudrage are considered by some to be the superior method for inducing a pleurodesis in MPE, as it may result in less fluid recurrence, which in turn may also result in reduced healthcare costs. However, there has not yet been a large trial which has been able to definitively answer which approach is better. The aim of the TAPPS trial is to determine which method is superior for the management of MPE in patients. We aim to recruit 330 patients from around the UK who will be randomised to receive one of the above treatments, and followed up for 6 months. The trial will have the potential to influence the care of patients with MPE both nationally and internationally.

Research activity codes: 6.4 SURGERY
Health categories: CANCER AND NEOPLASMS