Open versus laparoscopic liver resection for colorectal liver metastases (the Oslo-CoMet Study): study protocol for a randomized controlled trial

Åsmund Avdem Fretland, Airazat M Kazaryan, Bjørn Atle Bjørnbeth, Kjersti Flatmark, Marit Helen Andersen, Tor Inge Tønnessen, Gudrun Maria Waaler Bjørnelv, Morten Wang Fagerland, Ronny Kristiansen, Karl Øyri, Bjørn Edwin, Åsmund Avdem Fretland, Airazat M Kazaryan, Bjørn Atle Bjørnbeth, Kjersti Flatmark, Marit Helen Andersen, Tor Inge Tønnessen, Gudrun Maria Waaler Bjørnelv, Morten Wang Fagerland, Ronny Kristiansen, Karl Øyri, Bjørn Edwin

Abstract

Background: Laparoscopic liver resection is used in specialized centers all over the world. However, laparoscopic liver resection has never been compared with open liver resection in a prospective, randomized trial.

Methods/design: The Oslo-CoMet Study is a randomized trial into laparoscopic versus open liver resection for the surgical management of hepatic colorectal metastases. The primary outcome is 30-day perioperative morbidity. Secondary outcomes include 5-year survival (overall, disease-free and recurrence-free), resection margins, recurrence pattern, postoperative pain, health-related quality of life, and evaluation of the inflammatory response. A cost-utility analysis of replacing open surgery with laparoscopic surgery will also be performed. The study includes all resections for colorectal liver metastases, except formal hemihepatectomies, resections where reconstruction of vessels/bile ducts is necessary and resections that need to be combined with ablation. All patients will participate in an enhanced recovery after surgery program. A biobank of liver and tumor tissue will be established and molecular analysis will be performed.

Discussion: After 35 months of recruitment, 200 patients have been included in the trial. Molecular and immunology data are being analyzed. Results for primary and secondary outcome measures will be presented following the conclusion of the study (late 2015). The Oslo-CoMet Study will provide the first level 1 evidence on the benefits of laparoscopic liver resection for colorectal liver metastases.

Trial registration: The trial was registered in ClinicalTrals.gov (NCT01516710) on 19 January 2012.

Figures

Figure 1
Figure 1
Oslo-CoMet study flowchart. CEA, carcinoembryonic antigen; CT, computed tomography; ERAS, Enhanced Recovery After Surgery; p.o., postoperative; QoL, quality of life.
Figure 2
Figure 2
Oslo-CoMet study: overview of substudies and translational research. SF-36, Short Form 36; FDG-PET, fludeoxyglucose positron emission tomography; CT, Computed Tomography.

References

    1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011;61:69–90. doi: 10.3322/caac.20107.
    1. Curley SA. Outcomes after surgical treatment of colorectal cancer liver metastases. Semin Oncol. 2005;32:S109–11. doi: 10.1053/j.seminoncol.2005.06.011.
    1. Pawlik TM, Scoggins CR, Zorzi D, Abdalla EK, Andres A, Eng C, et al. Effect of surgical margin status on survival and site of recurrence after hepatic resection for colorectal metastases. Ann Surg. 2005;241:715–22. doi: 10.1097/01.sla.0000160703.75808.7d.
    1. Fernandez FG, Drebin JA, Linehan DC, Dehdashti F, Siegel BA, Strasberg SM. Five-year survival after resection of hepatic metastases from colorectal cancer in patients screened by positron emission tomography with F-18 fluorodeoxyglucose (FDG-PET) Ann Surg. 2004;240:438–47. doi: 10.1097/01.sla.0000138076.72547.b1.
    1. Rees M, Tekkis PP, Welsh FKS, O’Rourke T, John TG. Evaluation of long-term survival after hepatic resection for metastatic colorectal cancer: a multifactorial model of 929 patients. Ann Surg. 2008;247:125–35. doi: 10.1097/SLA.0b013e31815aa2c2.
    1. Mala T, Edwin B, Gladhaug I, Fosse E, Søreide O, Bergan A, et al. A comparative study of the short-term outcome following open and laparoscopic liver resection of colorectal metastases. Surg Endosc. 2002;16:1059–63. doi: 10.1007/s00464-001-9176-5.
    1. Carswell KA, Sagias FG, Murgatroyd B, Rela M, Heaton N, Patel AG. Laparoscopic versus open left lateral segmentectomy. BMC Surg. 2009;9:14. doi: 10.1186/1471-2482-9-14.
    1. Abu Hilal M, Di Fabio F, Teng MJ, Lykoudis P, Primrose JN, Pearce NW. Single-centre comparative study of laparoscopic versus open right hepatectomy. J Gastrointest Surg. 2011;15:818–23. doi: 10.1007/s11605-011-1468-z.
    1. Cai XJ, Yang J, Yu H, Liang X, Wang YF, Zhu ZY, et al. Clinical study of laparoscopic versus open hepatectomy for malignant liver tumors. Surg Endosc. 2008;22:2350–6. doi: 10.1007/s00464-008-9789-z.
    1. Lee KF, Chong CN, Wong J, Cheung YS, Wong J, Lai P. Long-term results of laparoscopic hepatectomy versus open hepatectomy for hepatocellular carcinoma: a case-matched analysis. World J Surg. 2011;35:2268–74. doi: 10.1007/s00268-011-1212-6.
    1. Belli G, Fantini C, D’Agostino A, Cioffi L, Langella S, Russolillo N, et al. Laparoscopic versus open liver resection for hepatocellular carcinoma in patients with histologically proven cirrhosis: short- and middle-term results. Surg Endosc. 2007;21:2004–11. doi: 10.1007/s00464-007-9503-6.
    1. Simillis C, Constantinides VA, Tekkis PP, Darzi A, Lovegrove R, Jiao L, et al. Laparoscopic versus open hepatic resections for benign and malignant neoplasms – a meta-analysis. Surgery. 2007;141:203–11. doi: 10.1016/j.surg.2006.06.035.
    1. Yin Z, Fan X, Ye H, Yin D, Wang J. Short- and long-term outcomes after laparoscopic and open hepatectomy for hepatocellular carcinoma: a global systematic review and meta-analysis. Ann Surg Oncol. 2013;20:1203–15. doi: 10.1245/s10434-012-2705-8.
    1. Fancellu A, Rosman AS, Sanna V, Nigri GR, Zorcolo L, Pisano M, et al. Meta-analysis of trials comparing minimally-invasive and open liver resections for hepatocellular carcinoma. J Surg Res. 2011;171:e33–45. doi: 10.1016/j.jss.2011.07.008.
    1. Jones C, Kelliher L, Dickinson M, Riga A, Worthington T, Scott MJ, et al. Randomized clinical trial on enhanced recovery versus standard care following open liver resection. Br J Surg. 2013;100:1015–24. doi: 10.1002/bjs.9165.
    1. McPhail MJW, Zeidan B, Zeidan S, Hallam MJ, Armstrong T, Primrose JN, et al. Laparoscopic versus open left lateral hepatic sectionectomy: a comparative study. Eur J Surg Oncol. 2008;34:1285–8. doi: 10.1016/j.ejso.2008.01.018.
    1. Mavros MN, de Jong M, Dogeas E, Hyder O, Pawlik TM. Impact of complications on long-term survival after resection of colorectal liver metastases. Br J Surg. 2013;100:711–8. doi: 10.1002/bjs.9060.
    1. Nguyen KT, Laurent A, Dagher I, Geller DA, Steel J, Thomas MT, et al. Minimally invasive liver resection for metastatic colorectal cancer: a multi-institutional, international report of safety, feasibility, and early outcomes. Ann Surg. 2009;250:842–8. doi: 10.1097/SLA.0b013e3181bc789c.
    1. Topal B, Tiek J, Fieuws S, Aerts R, Van Cutsem E, Roskams T, et al. Minimally invasive liver surgery for metastases from colorectal cancer: oncologic outcome and prognostic factors. Surg Endosc. 2012;26:2288–98. doi: 10.1007/s00464-012-2176-9.
    1. Buell JF, Gayet B, Han HS, Wakabayashi G, Kim K-H, Belli G, et al. Evaluation of stapler hepatectomy during a laparoscopic liver resection. HPB (Oxford) 2013;15:845–50. doi: 10.1111/hpb.12043.
    1. Shafaee Z, Kazaryan AM, Marvin MR, Cannon R, Buell JF, Edwin B, et al. Is laparoscopic repeat hepatectomy feasible? A tri-institutional analysis. J Am Coll Surg. 2011;212:171–9. doi: 10.1016/j.jamcollsurg.2010.10.012.
    1. Wakabayashi G. Towards the 2nd international consensus conference on laparoscopic liver resection. J Hepatobiliary Pancreat Sci. 2014;21:721–2. doi: 10.1002/jhbp.161.
    1. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet. 2009;374:1105–12. doi: 10.1016/S0140-6736(09)61116-8.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT. Statement: Updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;2010:834–40. doi: 10.1016/j.jclinepi.2010.02.005.
    1. Strasberg SM, Linehan DC, Hawkins WG. The accordion severity grading system of surgical complications. Ann Surg. 2009;250:177–86. doi: 10.1097/SLA.0b013e3181afde41.
    1. Porembka MR, Hall BL, Hirbe M, Strasberg SM. Quantitative weighting of postoperative complications based on the accordion severity grading system: demonstration of potential impact using the American College of Surgeons national surgical quality improvement program. J Am Coll Surg. 2010;210:286–98. doi: 10.1016/j.jamcollsurg.2009.12.004.
    1. Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien P-A. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013;258:1–7. doi: 10.1097/SLA.0b013e318296c732.
    1. Satava RM. Identification and reduction of surgical error using simulation. Minim Invasive Ther Allied Technol. 2005;14:257–61. doi: 10.1080/13645700500274112.
    1. Kazaryan AM, Røsok BI. Morbidity assessment in surgery: refinement proposal based on a concept of perioperative adverse events. ISRN Surg. 2013;2013:625093. doi: 10.1155/2013/625093.
    1. Mann C, Pouzeratte Y, Boccara G, Peccoux C, Vergne C, Brunat G, et al. Comparison of intravenous or epidural patient-controlled analgesia in the elderly after major abdominal surgery. Anesthesiology. 2000;92:433–41. doi: 10.1097/00000542-200002000-00025.
    1. Marret E, Remy C, Bonnet F, Postoperative Pain Forum Group Meta-analysis of epidural analgesia versus parenteral opioid analgesia after colorectal surgery. Br J Surg. 2007;94:665–73. doi: 10.1002/bjs.5825.
    1. Ahlers O, Nachtigall I, Lenze J, Goldmann A, Schulte E, Höhne C, et al. Intraoperative thoracic epidural anaesthesia attenuates stress-induced immunosuppression in patients undergoing major abdominal surgery. Br J Anaesth. 2008;101:781–7. doi: 10.1093/bja/aen287.
    1. Cardinale F, Mastrototaro MF, Cappiello A, Caffarelli C, Caimmi S, Barberi S, et al. Immunological modifications induced from products used during the perioperative period. Int J Immunopathol Pharmacol. 2011;24:S13–20.
    1. Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013;68:628–35. doi: 10.1111/anae.12191.
    1. van Dam RM, Hendry PO, Coolsen MME, Bemelmans MHA, Lassen K, Revhaug A, et al. Initial experience with a multimodal enhanced recovery programme in patients undergoing liver resection. Br J Surg. 2008;95:969–75. doi: 10.1002/bjs.6227.
    1. van Dam RM, Wong-Lun-Hing EM, van Breukelen GJP, Stoot JHMB, van der Vorst JR, Bemelmans MHA, et al. Open versus laparoscopic left lateral hepatic sectionectomy within an enhanced recovery ERAS® programme (ORANGE II-trial): study protocol for a randomised controlled trial. Trials. 2012;13:54. doi: 10.1186/1745-6215-13-54.
    1. Campbell M, and the DAMOCLES study group A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365:711–22. doi: 10.1016/S0140-6736(05)17776-9.
    1. Kvarnström A, Sokolov A, Swartling T, Kurlberg G, Mollnes TE, Bengtsson A. Alternative pathway activation of complement in laparoscopic and open rectal surgery. Scand J Immunol. 2012;76:49–53. doi: 10.1111/j.1365-3083.2012.02702.x.
    1. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83. doi: 10.1097/00005650-199206000-00002.
    1. Loge JH, Kaasa S. Short form 36 (SF-36) health survey: normative data from the general Norwegian population. Scand J Soc Med. 1998;26:250–8.
    1. Andersen MH, Mathisen L, Veenstra M, Oyen O, Edwin B, Digernes R, et al. Quality of life after randomization to laparoscopic versus open living donor nephrectomy: long-term follow-up. Transplantation. 2007;84:64–9. doi: 10.1097/01.tp.0000268071.63977.42.
    1. Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21:271–92. doi: 10.1016/S0167-6296(01)00130-8.
    1. Drummond MF. Methods for the economic evaluation of health care programmes. Oxford (UK): Oxford University Press; 2005.
    1. Blazeby JM, Fayers P, Conroy T, Sezer O, Ramage J, Rees M, et al. Validation of the European Organization for Research and Treatment of Cancer QLQ-LMC21 questionnaire for assessment of patient-reported outcomes during treatment of colorectal liver metastases. Br J Surg. 2009;96:291–8. doi: 10.1002/bjs.6471.
    1. Paice JA, Cohen FL. Validity of a verbally administered numeric rating scale to measure cancer pain intensity. Cancer Nurs. 1997;20:88–93. doi: 10.1097/00002820-199704000-00002.
    1. Jensen MP. The validity and reliability of pain measures in adults with cancer. J Pain. 2003;4:2–21. doi: 10.1054/jpai.2003.1.
    1. Nguyen KT, Gamblin TC, Geller DA. World review of laparoscopic liver resection - 2,804 patients. Ann Surg. 2009;250:831–41. doi: 10.1097/SLA.0b013e3181b0c4df.
    1. Dokmak S, Ftériche FS, Borscheid R, Cauchy F, Farges O, Belghiti J. 2012 Liver resections in the 21st century: we are far from zero mortality. HPB (Oxford) 2013;15:908–15. doi: 10.1111/hpb.12069.
    1. Li Q-G, Li P, Tang D, Chen J, Wang D-R. Impact of postoperative complications on long-term survival after radical resection for gastric cancer. World J Gastroenterol. 2013;19:4060–5. doi: 10.3748/wjg.v19.i25.4060.
    1. Cho JY, Han HS, Yoon Y-S, Hwang DW, Jung K, Kim YK. Postoperative complications influence prognosis and recurrence patterns in periampullary cancer. World J Surg. 2013;37:2234–41. doi: 10.1007/s00268-013-2106-6.
    1. Buell JF. Does laparoscopic liver resection mitigate complications? AHPBA. 2012;13:1–2.
    1. Kazaryan AM, Marangos IP, Røsok BI, Rosseland AR, Villanger O, Fosse E, et al. Laparoscopic resection of colorectal liver metastases: surgical and long-term oncologic outcome. Ann Surg. 2010;252:1005–12. doi: 10.1097/SLA.0b013e3181f66954.
    1. Olsen P. Årsrapport Helse Sør-Øst 2012.
    1. Hamady ZZR, Lodge JPA, Welsh FK, Toogood GJ, White A, John T, et al. One-millimeter cancer-free margin is curative for colorectal liver metastases: a propensity score case-match approach. Ann Surg. 2014;259:543–8. doi: 10.1097/SLA.0b013e3182902b6e.
    1. Kazaryan AM, Røsok BI. Margin status after laparoscopic resection of colorectal liver metastases: does a narrow resection margin have an influence on survival and local recurrence? HPB (Oxford) 2014;16:822–9. doi: 10.1111/hpb.12204.
    1. Karanicolas PJ, Farrokhyar F, Bhandari M. Practical tips for surgical research: blinding: who, what, when, why, how? Can J Surg. 2010;53:345–8.

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