VIdeo-assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer: a multi-centre randomised controlled trial with an internal pilot

Overview

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31615795/ protocol 2022 Results article in https://doi.org/10.1056/EVIDoa2100016 results (added 27/01/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36524582/ (added 19/12/2022)

Registry

who.int

Start Date

November 28, 2014

End Date

September 1, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Current participant inclusion criteria as of 08/01/2019:
•1\. Adults aged \=16 years of age
•2\. Able to give written consent, undergoing either:
•2\.1\. Lobectomy or bilobectomy for treatment of known or suspected primary lung cancer beyond lobar orifice\* in TNM8 stage cT1\-3 (by size criteria, equivalent to TNM7 stage cT1a\-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0\-1 and M0 or
•2\.2\. Undergoing frozen section biopsy with the intention to proceed with lobectomy or bilobectomy if primary lung cancer with a peripheral tumour beyond a lobar orifice\* in TNM8 stage cT1\-3 (by size criteria, equivalent to TNM7 stage cT1a\-2b) or cT3 (by virtue of 2 nodules in the same lobe), N0\-1 and M0 is confirmed
•3\. Disease suitable for both minimal access (VATS) and open surgery
•Previous participant inclusion criteria:
•1\. Adults aged \=16 years of age
•2\. Able to give written consent, undergoing either:
•2\.1\. Lobectomy for treatment of known or suspected primary lung cancer beyond lobular orifice in stage cT1a\-2b N0\-1 M0 or

•1\. Adults lacking capacity to consent
•2\. Previous malignancy that influences life expectancy
•3\. Patients in whom a pneumonectomy or non\-anatomic resection (e.g. wedge dissection) is planned
•4\. Patients with a serious concomitant disorder that would compromise patient safety during surgery
•5\. Planned robotic surgery