Video Assisted Thoracoscopic Lobectomy Versus Conventional Open Lobectomy For Lung Cancer, A Multi-Centre Randomised Controlled Trial With An Internal Pilot: The VIOLET Study
Funder: NIHR/HTA (project number 13/04/03)
Sponsor: Royal Brompton and Harefield NHS Foundation Trust
REC Number: 14/LO/2129
Status: Recruitment had finished to the main study and sub-study.
Lung cancer is the leading cause of cancer death worldwide and survival in the UK remains amongst the lowest in Europe. Surgery is the main method of managing early stage disease with over 5000 resections being performed for primary lung cancer within the UK in 2010. Of these, the majority (75%) involved surgical excision of the pulmonary lobe containing the tumour (lobectomy), which is the standard treatment strategy for patients with early stage non-small cell lung cancer.
This type of surgery can be undertaken via traditional open surgery or a form of keyhole surgery called video assisted thoracoscopic surgery (VATS). Both ways of performing the operation are currently used within the NHS and both aim to remove the lobe of the lung containing the tumour. However, at present, we do not know which offers the best treatment and recovery for patients.
Therefore, the aim of the VIOLET study is to generate high quality evidence to compare clinical and patient-reported outcomes between VATS and open surgery in a randomised controlled trial (RCT). A well designed and conducted RCT comparing the effectiveness and cost-effectiveness of VATS and open surgery is urgently needed to inform current NHS practice, health policy and individual surgeon and patient decision-making. Whilst surgery involves compete resection of the tumour, disease recurrence is common. Therefore, in addition to the main RCT patients were also offered the option to participate in a VIOLET sub-study, which aimed to determine an association between cancer DNA in the blood and disease recurrence and survival to 5 years.
The main study paper has been published, recruitment to the sub-study has finished.
The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.
Chief Investigator: Mr Eric Lim, Consultant Thoracic Surgeon, Royal Brompton Hospital
Further information can be found on Cancer Research UK