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Published in: Trials 1/2020

01-12-2020 | NSCLC | Study protocol

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

Authors: Jian Zhou, Chengwu Liu, Shulei Man, Mengyuan Lyu, Hu Liao, Nan Chen, Yuhui Cheng, Lunxu Liu

Published in: Trials | Issue 1/2020

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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).
Appendix
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Metadata
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
Authors
Jian Zhou
Chengwu Liu
Shulei Man
Mengyuan Lyu
Hu Liao
Nan Chen
Yuhui Cheng
Lunxu Liu
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4146-1

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