Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial
Abstract Background Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. However, scant data could be found in the literature regarding the optimal regimen for performing pleural lavage....
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| Format: | Article |
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BMC
2020-02-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-020-4146-1 |
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| author | Jian Zhou Chengwu Liu Shulei Man Mengyuan Lyu Hu Liao Nan Chen Yuhui Cheng Lunxu Liu |
| author_facet | Jian Zhou Chengwu Liu Shulei Man Mengyuan Lyu Hu Liao Nan Chen Yuhui Cheng Lunxu Liu |
| author_sort | Jian Zhou |
| collection | DOAJ |
| description | Abstract Background Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. However, scant data could be found in the literature regarding the optimal regimen for performing pleural lavage. To establish a proper volume of pleural lavage, we herein designed a protocol for a randomized controlled trial. Methods A total of 400 participants with non-small cell lung cancer undergoing video-assisted thoracoscopic surgery (VATS) lobectomy and systematic mediastinal lymph node dissection (MLND) will be randomly assigned to one of two groups: group A (500 mL pleural lavage fluid) and group B (3000 mL pleural lavage fluid). The primary outcomes include the levels of leukocytes, neutrophils, and inflammatory factors on the first postoperative day. The secondary outcomes include (i) the levels of leukocytes, neutrophils, and inflammatory factors on the second and third postoperative days; (ii) the incidence of postoperative fever on the first, second, and third postoperative days; (iii) the volumes of chest drainage within the first 3 operative days, the duration of drainage, and postoperative hospitalization; and (iv) the incidence of postoperative complications (incision infection, pain, atelectasis, hemorrhage, etc.) and the incidence of pleural effusion requiring thoracic puncture or drainage within 30 days after surgery. The main content of the analysis includes effectiveness and safety analysis. We will perform subgroup analyses to identify potential influence factors. Discussion As far as we know, this will be the first randomized controlled trial to compare the clinical outcomes between different volumes of pleural lavage fluid following VATS and MLND. Findings from this trial will determine the appropriate amount of pleural lavage before chest wall closure. Trial registration This study was registered with the Chinese Clinical Trial Registry ( on 17 March 2019. ChiCTR 1900021950). |
| first_indexed | 2024-12-10T21:26:33Z |
| format | Article |
| id | doaj.art-729cfe993bdc4ed6bd812ab1eb2b10ea |
| institution | Directory Open Access Journal |
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| language | English |
| last_indexed | 2024-12-10T21:26:33Z |
| publishDate | 2020-02-01 |
| publisher | BMC |
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| series | Trials |
| spelling | doaj.art-729cfe993bdc4ed6bd812ab1eb2b10ea2022-12-22T01:32:58ZengBMCTrials1745-62152020-02-012111710.1186/s13063-020-4146-1Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trialJian Zhou0Chengwu Liu1Shulei Man2Mengyuan Lyu3Hu Liao4Nan Chen5Yuhui Cheng6Lunxu Liu7Department of Thoracic Surgery, West China Hospital, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityWest China School of Medicine, Sichuan UniversityWest China School of Medicine, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityWest China School of Medicine, Sichuan UniversityDepartment of Thoracic Surgery, West China Hospital, Sichuan UniversityAbstract Background Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. However, scant data could be found in the literature regarding the optimal regimen for performing pleural lavage. To establish a proper volume of pleural lavage, we herein designed a protocol for a randomized controlled trial. Methods A total of 400 participants with non-small cell lung cancer undergoing video-assisted thoracoscopic surgery (VATS) lobectomy and systematic mediastinal lymph node dissection (MLND) will be randomly assigned to one of two groups: group A (500 mL pleural lavage fluid) and group B (3000 mL pleural lavage fluid). The primary outcomes include the levels of leukocytes, neutrophils, and inflammatory factors on the first postoperative day. The secondary outcomes include (i) the levels of leukocytes, neutrophils, and inflammatory factors on the second and third postoperative days; (ii) the incidence of postoperative fever on the first, second, and third postoperative days; (iii) the volumes of chest drainage within the first 3 operative days, the duration of drainage, and postoperative hospitalization; and (iv) the incidence of postoperative complications (incision infection, pain, atelectasis, hemorrhage, etc.) and the incidence of pleural effusion requiring thoracic puncture or drainage within 30 days after surgery. The main content of the analysis includes effectiveness and safety analysis. We will perform subgroup analyses to identify potential influence factors. Discussion As far as we know, this will be the first randomized controlled trial to compare the clinical outcomes between different volumes of pleural lavage fluid following VATS and MLND. Findings from this trial will determine the appropriate amount of pleural lavage before chest wall closure. Trial registration This study was registered with the Chinese Clinical Trial Registry ( on 17 March 2019. ChiCTR 1900021950).http://link.springer.com/article/10.1186/s13063-020-4146-1Pleural lavage fluidPulmonary surgeryNon-small cell lung cancerThoracic drainageRandomized controlled trial |
| spellingShingle | Jian Zhou Chengwu Liu Shulei Man Mengyuan Lyu Hu Liao Nan Chen Yuhui Cheng Lunxu Liu Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial Trials Pleural lavage fluid Pulmonary surgery Non-small cell lung cancer Thoracic drainage Randomized controlled trial |
| title | Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial |
| title_full | Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial |
| title_fullStr | Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial |
| title_full_unstemmed | Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial |
| title_short | Comparison of the clinical benefits for non-small cell lung cancer patients between different volume of pleural lavage fluid following video-assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection: study protocol for a randomized controlled trial |
| title_sort | comparison of the clinical benefits for non small cell lung cancer patients between different volume of pleural lavage fluid following video assisted thoracoscopic lobectomy and systematic mediastinal lymph node dissection study protocol for a randomized controlled trial |
| topic | Pleural lavage fluid Pulmonary surgery Non-small cell lung cancer Thoracic drainage Randomized controlled trial |
| url | http://link.springer.com/article/10.1186/s13063-020-4146-1 |
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