Pneumoperitoneum preconditioning for the prevention of renal function after laparoscopic partial nephrectomy: protocol for a double-blind randomised controlled trial

Changcheng Zhou, Luwei Xu, Zheng Xu, Yuzheng Ge, Liuhua Zhou, Feng Wang, Jingyu Liu, Gaojian Pan, Tianli Yang, Ruipeng Jia, Changcheng Zhou, Luwei Xu, Zheng Xu, Yuzheng Ge, Liuhua Zhou, Feng Wang, Jingyu Liu, Gaojian Pan, Tianli Yang, Ruipeng Jia

Abstract

Introduction: Renal ischaemia reperfusion injury is an inevitable pathophysiology in different clinical situations including laparoscopic partial nephrectomy (LPN), which can obviously decrease the renal function after surgery. Pneumoperitoneum preconditioning (PP) is a promising approach that can yield a protective effect on kidney, which has already been demonstrated in some animal models. The present study is designed to assess whether the PP can yield a clinical renoprotective role after LPN.

Methods and analysis: This study is a randomised, prospective, double-blind and parallel controlled clinical trial. Eligible participants will be patients with renal tumours and willing to choose elective LPN. Patients randomised to the treatment arm will receive PP consisted of three cycles of 5 min insufflation and 5 min desufflation before LPN, while the control arm will receive a sham operation. The primary endpoints are glomerular filtration rate and the level of serum cystatin C within 6 months after desufflation. The secondary endpoints are serum creatinine, estimated glomerular filtration rate, alanine transaminase, serum amylase, intestinal fatty acid binding protein, postoperative hospital stay, the incidence of adverse events and mortality in postoperative 6 months.

Ethics and dissemination: This study has been approved by the institutional ethics committee of Nanjing First Hospital. The results of this study will be reported faithfully through scientific conferences or published articles.

Trial registration number: NCT03822338.

Keywords: laparoscopic partial nephrectomy; pneumoperitoneum preconditioning; protocol; randomised controlled trial.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Schematic flow chart of the study. ALT, alanine transaminase; AMS, amylase; Cys C, cystatin C; eGFR, estimated glomerular filtration rate; GFR, glomerular filtration rate; I-FABP, intestinal fatty acid binding protein; PP, pneumoperitoneum preconditioning; SCr, serum creatinine.
Figure 2
Figure 2
Schematic interpretation of the experimental protocol. PP, pneumoperitoneum preconditioning.

References

    1. Scosyrev E, Messing EM, Sylvester R, et al. . Renal function after nephron-sparing surgery versus radical nephrectomy: results from EORTC randomized trial 30904. Eur Urol 2014;65:372–7. 10.1016/j.eururo.2013.06.044
    1. Huang WC, Levey AS, Serio AM, et al. . Chronic kidney disease after nephrectomy in patients with renal cortical tumours: a retrospective cohort study. Lancet Oncol 2006;7:735–40. 10.1016/S1470-2045(06)70803-8
    1. Ng AM, Shah PH, Kavoussi LR. Laparoscopic partial nephrectomy: a narrative review and comparison with open and robotic partial nephrectomy. J Endourol 2017;31:976–84. 10.1089/end.2017.0063
    1. Godoy G, Ramanathan V, Kanofsky JA, et al. . Effect of warm ischemia time during laparoscopic partial nephrectomy on early postoperative glomerular filtration rate. J Urol 2009;181:2438–45. 10.1016/j.juro.2009.02.026
    1. Funahashi Y, Hattori R, Yamamoto T, et al. . Ischemic renal damage after nephron-sparing surgery in patients with normal contralateral kidney. Eur Urol 2009;55:209–16. 10.1016/j.eururo.2008.07.048
    1. Leventi A, Argyra E, Avraamidou A, et al. . Attenuation of oxidative stress by ischemic preconditioning in an experimental model of intraabdominal hypertension. J Invest Surg 2015;28:253–60. 10.3109/08941939.2015.1031922
    1. Shao P, Qin C, Yin C, et al. . Laparoscopic partial nephrectomy with segmental renal artery clamping: technique and clinical outcomes. Eur Urol 2011;59:849–55. 10.1016/j.eururo.2010.11.037
    1. Gill IS, Patil MB, Abreu ALdeC, et al. . Zero ischemia anatomical partial nephrectomy: a novel approach. J Urol 2012;187:807–15. 10.1016/j.juro.2011.10.146
    1. Naya Y, Kawauchi A, Yoneda K, et al. . A comparison of cooling methods for laparoscopic partial nephrectomy. Urology 2008;72:687–9. 10.1016/j.urology.2007.12.043
    1. Ge Y-Z, Wu R, Xin H, et al. . Effects of ischemic preconditioning on the systemic and renal hemodynamic changes in renal ischemia reperfusion injury. Int J Clin Exp Pathol 2015;8:1128–40.
    1. Karabayirli S, Surgit O, Kasikara H, et al. . The effects of adding ischemic preconditioning during desflurane inhalation anesthesia or propofol total intravenous anesthesia on pneumoperitoneum-induced oxidative stress. Acta Chir Belg 2017;117:36–44. 10.1080/00015458.2016.1242215
    1. Ates E, Yilmaz S, Ihtiyar E, et al. . Preconditioning-Like amelioration of erythropoietin against laparoscopy-induced oxidative injury. Surg Endosc 2006;20:815–9. 10.1007/s00464-005-0428-7
    1. Yilmaz S, Koken T, Tokyol C, et al. . Can preconditioning reduce laparoscopy-induced tissue injury? Surg Endosc 2003;17:819–24. 10.1007/s00464-002-9096-z
    1. Feng Y, Jia R, Wu R, et al. . [Effects of pneumoperitoneum preconditioning on endothelial progenitor cells and renal protective mechanism in rats]. Zhonghua Yi Xue Za Zhi 2015;95:1248–52.
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200–7. 10.7326/0003-4819-158-3-201302050-00583
    1. Haber G-P, Gill IS. Laparoscopic partial nephrectomy: contemporary technique and outcomes. Eur Urol 2006;49:660–5. 10.1016/j.eururo.2006.02.001
    1. Chow SC, Wang H, Shao J. Sample Size Calculations in Clinical Research. 58 Second Edn Chapman & Hall/CRC Biostatistics Series, 2008.
    1. Huang J, Chen Y, Dong B, et al. . Effect of remote ischaemic preconditioning on renal protection in patients undergoing laparoscopic partial nephrectomy: a 'blinded' randomised controlled trial. BJU Int 2013;112:74–80. 10.1111/bju.12004
    1. Nesek-Adam V, Rasić Z, Vnuk D, et al. . Ischemic preconditioning decreases laparoscopy induced oxidative stress in the liver. Coll Antropol 2010;34:571–6.
    1. Bulbuloglu E, Yildiz H, Senoglu N, et al. . Protective effects of zinc, pentoxifylline, and N-acetylcysteine in an animal model of laparoscopy-induced ischemia/reperfusion injury of the small intestine. J Laparoendosc Adv Surg Tech A 2011;21:947–51. 10.1089/lap.2011.0194
    1. Avraamidou A, Marinis A, Asonitis S, et al. . The impact of ischemic preconditioning on hemodynamic, biochemical and inflammatory alterations induced by intra-abdominal hypertension: an experimental study in a porcine model. Langenbecks Arch Surg 2012;397:1333–41. 10.1007/s00423-012-0977-x

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