The increasing use of CT scans in routine follow up of colorectal cancer patients has led to earlier diagnosis of cancer deposits in the lungs (pulmonary metastases). These deposits can be removed by surgery (pulmonary metastasectomy) but this procedure carries risks as well as potential benefits. According to the location of the lung deposits, it may be necessary to remove a significant amount of normal lung tissue during the operation. Following surgery, some patients may be left with reduced lung function, which could affect their ability to conduct normal daily activities and negatively affect their QoL.
A recent survey showed that surgeons’ opinions vary widely in the types of patients they consider for pulmonary metastasectomy due to a lack of evidence regarding which types of patients benefit from it. The PulMiCC trial aims to investigate the risks and benefits of pulmonary metastasectomy to provide reliable evidence to guide surgeons in the future.
PulMiCC is a two stage randomised controlled trial. Approximately 1350 patients will be registered into stage 1 to provide 300 patients randomised into stage 2.
Stage 1 - registration
Eligible patients will provide consent for tests and evaluation according to the protocol and local practice guidelines. Following evaluation by the local multi-disciplinary team, patients for whom uncertainty exists whether surgery would be of benefit will be eligible for stage 2.
Stage 2 – randomisation
Eligible patients will be randomised equally between:
- Arm 1, active monitoring according to local practice guidelines (control)
- Arm 2, active monitoring according to local practice guidelines with pulmonary metastasectomy
QoL is an important part of this trial. Data will be collected directly from patients using three questionnaires (FACT An – L, EQ-5D-3L, 6 item short form STAI). It is hoped that analysis of the QoL and clinical data collected in the trial will provide robust evidence on the risks and benefits of pulmonary metastasectomy to guide surgeons and patients in the future.