TACTIC
Research type
Research Study
Full title
The Randomised Thoracoscopic Talc Poudrage and Indwelling Pleural Catheters versus Thoracoscopic Talc Poudrage only in Malignant Pleural Effusion trial.
IRAS ID
289120
Contact name
Nick Maskell
Contact email
Sponsor organisation
North Bristol NHS Trust
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
Patients with cancer can develop fluid around the lung as part of their illness. This is called a malignant pleural effusion. The pleura are thin layers which cover the outside surface of the lung. Fluid build-up between these layers can compress the lung and cause breathlessness. The TACTIC randomized controlled trial will compare one way of managing malignant pleural effusions (MPE) with another.
A current method for managing fluid build-up is a procedure called a thoracoscopy to drain the fluid away, with talc pleurodesis to ‘dry up’ or stop the fluid from returning.
However, even despite talc pleurodesis, pleural effusions may reaccumulate causing recurrent breathlessness in up to 25% of patients. A second procedure, to insert an Indwelling Pleural Catheter (IPC), is often required. IPCs are flexible chest tubes, which can remain in place long term to allow drainage of the pleural effusion at home.
This study combines a thoracoscopy and talc pleurodesis with an IPC insertion in the same procedure. We want to know whether this is better for patients in terms of their breathing control and the overall time they spend in hospital.
We aim to recruit 124 participants from around the UK with symptomatic MPE to assess the effect of combined procedures. The trial will have the potential to influence the care of patients with MPE both nationally and internationally.
Lay summary of study results:
There was no difference in the number of days patients spent in hospital between the two groups: one receiving medical thoracoscopy with talc poudrage and an indwelling pleural catheter (IPC), and the other receiving medical thoracoscopy with talc poudrage alone.
Breathlessness levels were similar in both groups.
However, patients who also received an IPC needed fewer additional procedures during the trial.
Side effects were similar in both groups, and the addition of an IPC did not cause more problems for patients.
These results suggest that adding an IPC at the time of medical thoracoscopy and talc poudrage is just as safe and effective as the procedure without it. Placing an IPC at the same time may act as a back-up if the talc poudrage does not work and the fluid comes back, potentially reducing the need for further procedures.
REC name
London - Brent Research Ethics Committee
REC reference
21/LO/0495
Date of REC Opinion
8 Sep 2021
REC opinion
Further Information Favourable Opinion