Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial

Paolo Mendogni, Alessandra Mazzucco, Alessandro Palleschi, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Francesco Damarco, Emilia Privitera, Jacopo Fumagalli, Gianluca Bonitta, Mario Nosotti, Davide Tosi, Paolo Mendogni, Alessandra Mazzucco, Alessandro Palleschi, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Francesco Damarco, Emilia Privitera, Jacopo Fumagalli, Gianluca Bonitta, Mario Nosotti, Davide Tosi

Abstract

Background: Video-assisted thoracoscopic surgery (VATS) lobectomy is currently the recommended approach for treating early-stage non-small cell lung cancer (NSCLC). Different VATS approaches have been proposed so far, and the actual advantages of one technique over the other are still under debate. The aim of our study is to compare postoperative pain and analgesic drug consumption in uniportal VATS and triportal VATS for pulmonary lobectomy in early-stage lung cancer patients.

Methods: This study is a single-center, prospective, two-arm, parallel-group, randomized controlled trial. It is designed to compare uniportal video-assisted thoracic surgery (u-VATS) and three-port video-assisted thoracic surgery (t-VATS) in terms of postoperative pain. The trial will enroll 120 patients with a 1:1 randomization. The primary outcome is the assessment of analgesic drug consumption. Secondary outcomes are postoperative pain measurement, evaluation of postoperative pulmonary function, and metabolic recovery after pulmonary lobectomy.

Discussion: The choice of which VATS approach to adopt for treating patients undergoing pulmonary resection mostly depends on the surgeon's preferences; therefore, it is hard to prove whether one VATS technique is superior to the other. Moreover, postoperative analgesic protocols vary consistently among different centers. To date, only a few studies have evaluated the effects of the most popular VATS techniques. There is no evidence about the difference between multiport VATS and u-VATS in terms of postoperative pain. We hope that the results of our trial will provide valuable information on the outcomes of these different surgical approaches.

Trial registration: ClinicalTrials.gov NCT03240250 . Registered on 07 August 2017; retrospectively registered.

Keywords: Lung cancer; Postoperative pain; Pulmonary lobectomy; Thoracic surgery; Uniportal; VATS.

Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Study process schedule (according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines). t0 day of surgery, t1 postoperative day (POD) 1, t2 POD 2, t3 POD 3, t4 POD 4, t5 POD 5, t6 POD 6, t7 POD 7, t8 POD 8, t15 POD 15, t30 POD 30, u-VATS uniportal video-assisted thoracic surgery lobectomy, t-VATS three-portal video-assisted thoracic surgery lobectomy, NRS numeric rating scale, PFTs pulmonary function tests (spirometry), PAL persistent air leaks
Fig. 2
Fig. 2
Trial flow chart

References

    1. Howington JA, Blum MG, Chang AC, et al. Treatment of stage I and II non-small cell lung cancer: diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143(5 Suppl):e278S–e313S.
    1. Detterbeck F. Thoracoscopic versus open lobectomy debate: the pro argument. Thorac Surg Sci. 2009;6:Doc04.
    1. Zhang R, Ferguson MK. Video-assisted versus open lobectomy in patients with compromised lung function: a literature review and meta-analysis. PLoS One. 2015;10(7):e0124512. doi: 10.1371/journal.pone.0124512.
    1. Bendixen M, Jørgensen OD, Kronborg C, et al. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016;17:836–844. doi: 10.1016/S1470-2045(16)00173-X.
    1. Zieliński M, Nabialek T, Pankowski J. Transcervical uniportal pulmonary lobectomy. J Vis Surg. 2018;4:42. doi: 10.21037/jovs.2018.02.02.
    1. Hernandez-Arenas LA, Lin L, Yang Y, et al. Initial experience in uniportal subxiphoid video-assisted thoracoscopic surgery for major lung resections. Eur J Cardiothorac Surg. 2016;50(6):1060–1066. doi: 10.1093/ejcts/ezw189.
    1. Dunning J, Elsaegh M, Nardini M, et al. Microlobectomy: a novel form of endoscopic lobectomy. Innovations (Phila) 2017;12(4):247–253. doi: 10.1097/imi.0000000000000394.
    1. Hansen HJ, Petersen RH. Video-assisted thoracoscopic lobectomy using a standardized three-port anterior approach - the Copenhagen experience. Ann Cardiothorac Surg. 2012;1:70–76.
    1. Tosi D, Nosotti M, Bonitta G, et al.; Italian VATS Group. Uniportal and three-portal video-assisted thoracic surgery lobectomy: analysis of the Italian video-assisted thoracic surgery group database. Interact Cardiovasc Thorac Surg 2019;29(5):714–721.
    1. McKenna RJ, Jr, Houck W, Fuller CB. Video-assisted thoracic surgery lobectomy: experience with 1,100 cases. Ann Thorac Surg. 2006;81(2):421–425. doi: 10.1016/j.athoracsur.2005.07.078.
    1. Scott WJ, Allen MS, Darling G, et al. Video-assisted thoracic surgery versus open lobectomy for lung cancer: a secondary analysis of data from the American College of Surgeons Oncology Group Z0030 randomized clinical trial. J Thorac Cardiovasc Surg. 2010;139(4):976–981. doi: 10.1016/j.jtcvs.2009.11.059.
    1. Gonzalez D, Paradela M, Garcia J, et al. Single-port video-assisted thoracoscopic lobectomy. Interact Cardiovasc Thorac Surg. 2011;12:514–515. doi: 10.1510/icvts.2010.256222.
    1. Bertolaccini L, Batirel H, Brunelli A, et al. Uniportal video-assisted thoracic surgery lobectomy: a consensus report from the Uniportal VATS Interest Group (UVIG) of the European Society of Thoracic Surgeons (ESTS) Eur J Cardiothorac Surg. 2019;56(2):224–229. doi: 10.1093/ejcts/ezz133.
    1. Nosotti M, Musso V. A different video-assisted thoracoscopic approach for every patient or for every surgeon? Future Oncol. 2019. 10.2217/fon-2018-0755 [Epub ahead of print].
    1. Rocco G, Martucci N, La Manna C, et al. Ten-year experience on 644 patients undergoing single-port (uniportal) video-assisted thoracoscopic surgery. Ann Thorac Surg. 2013;96(2):434–438. doi: 10.1016/j.athoracsur.2013.04.044.
    1. Perna V, Carvajal AF, Torrecilla JA, et al. Uniportal video-assisted thoracoscopic lobectomy versus other video-assisted thoracoscopic lobectomy techniques: a randomized study. Eur J Cardiothorac Surg. 2016;50(3):411–415. doi: 10.1093/ejcts/ezw161.
    1. Ng CSH, MacDonald JK, Gilbert S, et al. Expert consensus statement on optimal approach to lobectomy for non-small cell lung cancer. Innovations (Phila). 2019;14(2):87–89. doi: 10.1177/1556984519837007.
    1. Ng CSH, MacDonald JK, Gilbert S, et al. Optimal approach to lobectomy for non-small cell lung cancer: systemic review and meta-analysis. Innovations (Phila) 2019;14(2):90–116. doi: 10.1177/1556984519837027.
    1. Rosenberger WF, Lachin JM. Randomization in clinical trials. Hoboken: Wiley; 2002.
    1. Longrois D, Hoeft A, De Hert S. 2014 European Society of Cardiology/European Society of Anaesthesiology guidelines on non-cardiac surgery: cardiovascular assessment and management: a short explanatory statement from the European Society of Anaesthesiology members who participated in the European Task Force. Eur J Anaesthesiol. 2014;31(10):513–516. doi: 10.1097/EJA.0000000000000155.
    1. Core Team R. R: a language and environment for statistical computing. Vienna, Austria: R Foundation for StatisticalComputing; 2019.
    1. Jutley RS, Khalil MW, Rocco G. Uniportal vs standard three-port VATS technique for spontaneous pneumothorax: comparison of post-operative pain and residual paraesthesia. Eur J Cardiothorac Surg. 2005;28(1):43–46. doi: 10.1016/j.ejcts.2005.02.039.
    1. Nosotti M, Rosso L, Tosi D, et al. Preventive analgesia in thoracic surgery: controlled, randomized, double blinded study. Eur J Cardiothorac Surg. 2015;48:428–434. doi: 10.1093/ejcts/ezu467.
    1. LoMauro A, Aliverti A, Chiesa M, Cattaneo M, Privitera E, Tosi D, Nosotti M, Santambrogio L, Palleschi A. Ribcage kinematics during exercise justifies thoracoscopic versus postero-lateral thoracotomy lobectomy prompt recovery. Eur J Cardiothorac Surg. 2017;52(6):1197–1205. doi: 10.1093/ejcts/ezx174.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅