ISRCTN13472721已完成未知
VIdeo-assisted thoracoscopic lobectomy versus conventional Open LobEcTomy for lung cancer: a multi-centre randomised controlled trial with an internal pilot
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 503
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •2.2. Undergoing frozen section biopsy with the intention to proceed with lobectomy if primary lung cancer with a peripheral tumour beyond a lobular orifice in stage cT1a-2b N0-1 M0 is confirmed
- •3. Disease suitable for both minimal access (VATS) and open surgery
排除标准
- •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
研究者
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