LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial)
Introduction Lung cancer was the most common malignancy and the leading cause of cancer-related death in China or worldwide, and surgery is still the preferred treatment for early-stage non-small cell lung cancer (NSCLC). The pattern of lymph node metastasis was found potentially lobe specific, and...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2022-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/12/8/e056043.full |
| _version_ | 1797999697705566208 |
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| author | Xiaojun Tang Kai Xu Weijia Huang Han-Yu Deng Zhi-Zhen Ren Yi-Feng Wang Da-Xing Zhu Qinghua Zhou |
| author_facet | Xiaojun Tang Kai Xu Weijia Huang Han-Yu Deng Zhi-Zhen Ren Yi-Feng Wang Da-Xing Zhu Qinghua Zhou |
| author_sort | Xiaojun Tang |
| collection | DOAJ |
| description | Introduction Lung cancer was the most common malignancy and the leading cause of cancer-related death in China or worldwide, and surgery is still the preferred treatment for early-stage non-small cell lung cancer (NSCLC). The pattern of lymph node metastasis was found potentially lobe specific, and thus, lobe-specific lymph node dissection (L-SLND) was proposed to be an alternative to systematic lymph node dissection (SLND) for the treatment of early-stage NSCLC.Methods and analysis The LobE-Specific lymph node diSsectiON trial is a single-institutional, randomised, double-blind and parallel controlled trial to investigate the feasibility of L-SLND in clinically diagnosed stage IA1-2 NSCLC with ground-glass opacity components (≥50%). The intraoperative frozen section examination of surgical tissues confirms the histological type of NSCLC. We hypothesise that L-SLND (experimental group) is not inferior to SLND (control group) and intend to include 672 participants for the experimental group and 672 participants for the control group with a follow-up duration of 60 months. The primary outcomes are 5-year disease-free survival and 5-year overall survival. The secondary outcomes are metastatic lymph node ratio, postoperative complication incidence and mortality, duration of operation, duration of anaesthesia (min), the volume of bleeding (mL) and drainage volume. The intention-to-treat analysis would be performed in the trial.Ethics and dissemination This trial was approved by the ethics committee on biomedical research, West China Hospital of Sichuan University (2021-332). Informed consent would be obtained from all participants, and dissemination activities would include academic conference presentations and peer-reviewed publications.Trial registration number This trial was registered in the Chinese Clinical Trial Registry, ChiCTR2100048415. |
| first_indexed | 2024-04-11T11:08:50Z |
| format | Article |
| id | doaj.art-b27e845c651144af80ba26cb2004d9f4 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-04-11T11:08:50Z |
| publishDate | 2022-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-b27e845c651144af80ba26cb2004d9f42022-12-22T04:28:05ZengBMJ Publishing GroupBMJ Open2044-60552022-08-0112810.1136/bmjopen-2021-056043LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial)Xiaojun Tang0Kai Xu1Weijia Huang2Han-Yu Deng3Zhi-Zhen Ren4Yi-Feng Wang5Da-Xing Zhu6Qinghua Zhou71 Department of Rheumatology and Immunology, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, ChinaAffiliated Clinical Medical Institute of Fujian Medical University, Fujian Provincial Hospital, Fuzhou, Fujian, ChinaLung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaWest China School of Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaLung Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan, ChinaIntroduction Lung cancer was the most common malignancy and the leading cause of cancer-related death in China or worldwide, and surgery is still the preferred treatment for early-stage non-small cell lung cancer (NSCLC). The pattern of lymph node metastasis was found potentially lobe specific, and thus, lobe-specific lymph node dissection (L-SLND) was proposed to be an alternative to systematic lymph node dissection (SLND) for the treatment of early-stage NSCLC.Methods and analysis The LobE-Specific lymph node diSsectiON trial is a single-institutional, randomised, double-blind and parallel controlled trial to investigate the feasibility of L-SLND in clinically diagnosed stage IA1-2 NSCLC with ground-glass opacity components (≥50%). The intraoperative frozen section examination of surgical tissues confirms the histological type of NSCLC. We hypothesise that L-SLND (experimental group) is not inferior to SLND (control group) and intend to include 672 participants for the experimental group and 672 participants for the control group with a follow-up duration of 60 months. The primary outcomes are 5-year disease-free survival and 5-year overall survival. The secondary outcomes are metastatic lymph node ratio, postoperative complication incidence and mortality, duration of operation, duration of anaesthesia (min), the volume of bleeding (mL) and drainage volume. The intention-to-treat analysis would be performed in the trial.Ethics and dissemination This trial was approved by the ethics committee on biomedical research, West China Hospital of Sichuan University (2021-332). Informed consent would be obtained from all participants, and dissemination activities would include academic conference presentations and peer-reviewed publications.Trial registration number This trial was registered in the Chinese Clinical Trial Registry, ChiCTR2100048415.https://bmjopen.bmj.com/content/12/8/e056043.full |
| spellingShingle | Xiaojun Tang Kai Xu Weijia Huang Han-Yu Deng Zhi-Zhen Ren Yi-Feng Wang Da-Xing Zhu Qinghua Zhou LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) BMJ Open |
| title | LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) |
| title_full | LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) |
| title_fullStr | LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) |
| title_full_unstemmed | LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) |
| title_short | LobE-Specific lymph node diSsectiON for clinical early-stage non-small cell lung cancer: protocol for a randomised controlled trial (the LESSON trial) |
| title_sort | lobe specific lymph node dissection for clinical early stage non small cell lung cancer protocol for a randomised controlled trial the lesson trial |
| url | https://bmjopen.bmj.com/content/12/8/e056043.full |
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