Abstract
BackgroundPleural 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.MethodsA 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.DiscussionAs 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 registrationThis study was registered with the Chinese Clinical Trial Registry ( on 17 March 2019. ChiCTR 1900021950).
Highlights
Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection
Intraoperative pleural lavage cytology detected before closure could present a higher prognostic value than pleural lavage cytology detected before thoracotomy
Study objective This study aims to identify the effects of different volumes of pleural lavage fluid on perioperative outcomes of patients with non-small cell lung cancer (NSCLC) following video-assisted thoracoscopic surgery (VATS) lobectomy and mediastinal lymph node dissection (MLND)
Summary
Pleural lavage is regularly performed before closing the chest wall in pulmonary surgeries to prevent pleural implantation of tumor cells and postoperative infection. Pleural lavage is routinely performed before closing the chest wall, to rinse off residual tumor cells and tissues and ideally prevent pleural implantation of tumor and postoperative infection [1]. If the volume of pleural lavage is too small, the residual tumor cells and tissue cannot be washed away, which may result in increased absorption of inflammatory mediators, fevers, and even severe inflammatory reactions [11]. It could affect prognosis and prolong hospitalization [12]. Considering clinical practice and the literature [7, 8], we decided to test two volumes of pleural lavage: 500 and 3000 mL
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