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 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 propervolume of pleural lavage, we herein designed this randomized controlled trial. Methods: A total of 400 participants with non-small cell lung cancer (NSCLC) undergoing video-assisted thoracoscopic surgery (VATS) lobectomy and systematic mediastinal lymph node dissection (MLND) will be randomly assigned into 2 groups: Group A (500ml pleural lavage fluid) and Group B (3000ml pleural lavage fluid). The primary outcomes include the levels of leukocytes, neutrophils, inflammatory factors on the first postoperative day. The secondary outcomes include: (i) the levels of leukocytes, neutrophils, inflammatory factors on the second and third postoperative day; (ii) the incidence of postoperative fever on the first, second and third postoperative day; (iii) the volumes of chest drainage within the first 3 operative days, the duration of drainage, and postoperative hospitalization; (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: This first randomized controlled trial is expected to compare the clinical outcomes between different volumes of pleural lavage fluid following VATS and MLND, and provide us evidence to develop a standardized procedure of pleural lavage before closing chest wall in lung cancer operation. Trial registration number: This study has been registered with the Chinese Clinical Trial Registry (ChiCTR1900021950) on 17 March 2019. The URL of the trial registry record is http://www.chictr.org.cn/listbycreater.aspx.