Please select the eligibility criteria that correspond to the clinical trial below.
Title: MesoTRAP: A Pilot Clinical Trial and Feasibility Study Comparing Video-assisted Thoracoscopic Partial Pleurectomy/Decortication With Indwelling Pleural Catheter in Patients With Trapped Lung Due to Malignant Pleural Mesothelioma Designed to Address Recruitment and Randomisation Uncertainties and Sample Size Requirements for a Phase III Trial.
Brief Summary: Malignant pleural mesothelioma is a cancer, caused by asbestos, which currently affects 2500 people in the UK each year. The main symptom is breathlessness caused by fluid building up in the space between the lung and the chest wall (pleural effusion). Treatment involves draining the fluid to allow the lung to re-expand (pleurodesis). However, sometimes tumour growth over the surface of the lung can prevent it from re-expanding. This 'trapped' lung results in fluid re-accumulation and repeated drainage which can lead to discomfort and multiple hospital visits.

One approach to dealing with 'trapped' lung in mesothelioma is to insert a thin tube (Indwelling Pleural Catheter - IPC) into the space around the lung. The tube can stay in place for a long time allowing patients to drain off fluid at home.

Another approach is a keyhole surgical operation (video-assisted thoracoscopic partial pleurectomy/decortication - VAT-PD) to remove as much tumour as possible from the lining of the lung to allow it to re-expand.

While both approaches are currently offered in clinical practice, it is not known which of the two is most effective at relieving breathlessness. The only way to find out is to conduct a research trial comparing the two. The Investigators plan to do this, but first of all need to carry out a small pilot study to collect information necessary to help plan the full study.


Options:
A: Inclusion Criteria:

* Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:

  1. Pleural effusion with histocytologically proven pleural malignancy OR
  2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
  3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
* Degree of breathlessness for which therapeutic pleural intervention would be offered
* Age \>18 years
* Expected survival \> 3 months
* Written Informed Consent

Exclusion Criteria:

* Females who are pregnant or lactating
* Clinical suspicion of non-expansile lung for which talc pleurodesis would not be offered
* Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
* Previous ipsilateral failed talc pleurodesis
* Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
* Any contraindication to chest drain or IPC insertion, including:

Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC tunnel site

- Any contraindication to MRI scanning, including:

Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign body Previously documented reaction to Gadolinium-containing intravenous contrast agent Significant renal impairment (eGFR\<30 ml/min)
B: Inclusion Criteria:

* Malignant pleural effusion confirmed by cytological analysis of pleural fluid and/or pleural biopsy;
* Recurrent pleural effusion with symptoms;
* Chest radiography with lung expansion after thoracocentesis;
* Karnofsky Performance Status \> 70;
* Written informed patient consent were obtained.

Exclusion Criteria:

* Hemorrhagic diathesis;
* Active infection;
* Cutaneous infiltration;
* Patients unable to understand the questionnaires;
* Age: \> 90 yo or \< 18 yo.
C: DISEASE CHARACTERISTICS:

* Confirmed or suspected mesothelioma

  * Any subtype allowed
* Pleural effusion must be present

PATIENT CHARACTERISTICS:

* Clinically fit and suitable for video-assisted thoracoscopic cytoreductive pleurectomy
* Prior malignancy allowed provided it no longer requires treatment AND patient has a confirmed diagnosis of mesothelioma

PRIOR CONCURRENT THERAPY:

* No prior attempted pleurodesis by any approach
D: Inclusion Criteria:

1. Pathologically confirmed MPM
2. Trapped lung, defined as a 'clinically significant trapped lung requiring intervention in the opinion of the clinical team"
3. Pleural effusion present (following re-accumulation)
4. Considered by the clinical team to be suitable and fit enough to undergo VAT-PD
5. Community services or patient/carer able to drain IPC at least twice weekly
6. Considered by the clinical team to be equally suitable for treatment with VAT-PD or IPC, and therefore eligible for treatment allocation by randomisation.
7. Patient willing to receive either VAT-PD or IPC and attend the respective designated centre for their treatment
8. Expected survival of at least 4 months, as assessed by managing clinician
9. Age ≥ 18 years
10. Able to provide informed consent

Exclusion Criteria:

1. Lung re-expands fully following pleural fluid drainage i.e. no entrapment
2. Evidence of active pleural infection
3. Current participation in an RCT or CTIMP
4. Females: pregnant or lactating

Answer: D