We tested the feasibility of a simultaneous resection clinical trial in patients with synchronous colorectal cancer liver metastases to obtain the necessary information to plan a randomized trial.

Methods

Multicenter feasibility single-arm trial enrolling patients with synchronous colorectal cancer liver metastases eligible for simultaneous resection. Prespecified criteria for feasibility were: proportion of eligible patients enrolled ≥66%, and the proportion of enrolled patients who completed simultaneous resection ≥75%. The prespecified 90-day major postoperative complication rate was 30%.

Results

Of 61 eligible patients from February 2017 to August 2019, 41 were enrolled (67%; 95% confidence interval [CI], 55%–78%), 32 underwent simultaneous resection (78%; 95% CI, 63%–88%). Four patients were not enrolled due to the surgeon's preference, three were due to the complexity of resection (right hepatectomy and low anterior resection). Intraoperative complications during liver resection (n = 4) and progression of disease (n = 4) were the main reasons for not undergoing simultaneous resection. The 90-day incidence of major complications was 41% (95% CI, 16%–58%) and the 90-day postoperative mortality was 6% (95% CI, 1.7%–20%).

Conclusion

According to prespecified criteria, enrolling patients with synchronous colorectal cancer liver metastases to a trial of simultaneous resection is feasible; however, it is associated with higher than anticipated 90-day postoperative complications.

Open Research

DATA AVAILABILITY STATEMENT

The data that support the findings of this study are available from the corresponding author upon reasonable request.

Supporting Information

REFERENCES

1 Canadian Cancer Statistics Advisory Committee. Canadian Cancer Statistics 2019. Canadian Cancer Society; 2019.
Google Scholar
2Adam R, de Gramont A, Figueras J, et al. Managing synchronous liver metastases from colorectal cancer: a multidisciplinary international consensus. Cancer Treat Rev. 2015; 41(9): 729-741.
10.1016/j.ctrv.2015.06.006
PubMed Web of Science® Google Scholar
3Bogach J, Wang J, Griffiths C, et al. Simultaneous versus staged resection for synchronous colorectal liver metastases: a population-based cohort study. Int J Surg. 2020; 74: 68-75.
10.1016/j.ijsu.2019.12.009
PubMed Web of Science® Google Scholar
4Benson AB, Venook AP, Al-Hawary MM, et al. Rectal cancer, version 2.2018, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2018; 16(7): 874-901.
10.6004/jnccn.2018.0061
PubMed Web of Science® Google Scholar
5Engstrom PF, Arnoletti JP, Benson AB, et al. NCCN clinical practice guidelines in oncology: colon cancer. J Natl Compr Canc Netw. 2009; 7(8): 778-831.
10.6004/jnccn.2009.0056
PubMed Web of Science® Google Scholar
6Serrano PE, Gu CS, Husien M, et al. Risk factors for survival following recurrence after first liver resection for colorectal cancer liver metastases. J Surg Oncol. 2019; 120: 1420-1426.
10.1002/jso.25735
PubMed Web of Science® Google Scholar
7Kim HS, Lee JM, Kim HS, et al. Prognosis of synchronous colorectal liver metastases after simultaneous curative-intent surgery according to primary tumor location and KRAS mutational status. Ann Surg Oncol. 2020; 27(13): 5150-5158.
10.1245/s10434-020-09041-0
PubMed Web of Science® Google Scholar
8Boudjema K, Locher C, Sabbagh C, et al. Simultaneous versus delayed resection for initially resectable synchronous colorectal cancer liver metastases: a prospective, open-label, randomized, controlled trial. Ann Surg. 2021; 273(1): 49-56.
10.1097/SLA.0000000000003848
PubMed Web of Science® Google Scholar
9Vallance AE, van der Meulen J, Kuryba A, et al. The timing of liver resection in patients with colorectal cancer and synchronous liver metastases: a population-based study of current practice and survival. Colorectal Dis. 2018; 20(6): 486-495.
10.1111/codi.14019
CAS PubMed Web of Science® Google Scholar
10Abelson JS, Michelassi F, Sun T, et al. Simultaneous resection for synchronous colorectal liver metastasis: the new standard of care? J Gastrointest Surg. 2017; 21(6): 975-982.
10.1007/s11605-017-3422-1
PubMed Web of Science® Google Scholar
11Idrees JJ, Bagante F, Gani F, et al. Population level outcomes and costs of single stage colon and liver resection versus conventional two-stage approach for the resection of metastatic colorectal cancer. HPB. 2019; 21(4): 456-464.
10.1016/j.hpb.2018.08.007
PubMed Web of Science® Google Scholar
12Serrano PE, Gafni A, Parpia S, et al. Simultaneous resection of colorectal cancer with synchronous liver metastases (RESECT), a pilot study. Int J Surg Protoc. 2018; 8: 1-6.
10.1016/j.isjp.2018.01.001
CAS PubMed Web of Science® Google Scholar
13Bismuth H. Revisiting liver anatomy and terminology of hepatectomies. Ann Surg. 2013; 257(3): 383-386.
10.1097/SLA.0b013e31827f171f
PubMed Web of Science® Google Scholar
14Strasberg SM. Nomenclature of hepatic anatomy and resections: a review of the Brisbane 2000 system. J Hepatobiliary Pancreat Surg. 2005; 12(5): 351-355.
10.1007/s00534-005-0999-7
PubMed Web of Science® Google Scholar
15Reddy SK, Pawlik TM, Zorzi D, et al. Simultaneous resections of colorectal cancer and synchronous liver metastases: a multi-institutional analysis. Ann Surg Oncol. 2007; 14(12): 3481-3491.
10.1245/s10434-007-9522-5
PubMed Web of Science® Google Scholar
16Chen H, Merchant NB, Didolkar MS. Hepatic resection using intermittent vascular inflow occlusion and low central venous pressure anesthesia improves morbidity and mortality. J Gastrointest Surg. 2000; 4(2): 162-167.
10.1016/S1091-255X(00)80052-9
CAS PubMed Web of Science® Google Scholar
17Hughes MJ, Ventham NT, Harrison EM, Wigmore SJ. Central venous pressure and liver resection: a systematic review and meta-analysis. HPB. 2015; 17(10): 863-871.
10.1111/hpb.12462
PubMed Web of Science® Google Scholar
18Wright JR, Bouma S, Dayes I, et al. The importance of reporting patient recruitment details in phase III trials. J Clin Oncol. 2006; 24(6): 843-845.
10.1200/JCO.2005.02.6005
PubMed Web of Science® Google Scholar
19Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004; 240(2): 205-213.
10.1097/01.sla.0000133083.54934.ae
PubMed Web of Science® Google Scholar
20Slankamenac K, Graf R, Barkun J, Puhan MA, Clavien PA. The comprehensive complication index: a novel continuous scale to measure surgical morbidity. Ann Surg. 2013; 258(1): 1-7.
10.1097/SLA.0b013e318296c732
PubMed Web of Science® Google Scholar
21Chua HK, Sondenaa K, Tsiotos GG, Larson DR, Wolff BG, Nagorney DM. Concurrent vs. staged colectomy and hepatectomy for primary colorectal cancer with synchronous hepatic metastases. Dis Colon Rectum. 2004; 47(8): 1310-1316.
10.1007/s10350-004-0586-z
PubMed Web of Science® Google Scholar
22Serrano PE, Gafni A, Gu CS, et al. Positron emission tomography-computed tomography (PET-CT) versus No PET-CT in the management of potentially resectable colorectal cancer liver metastases: cost implications of a randomized controlled trial. J Oncol Pract. 2016; 12(7): e765-e774.
10.1200/JOP.2016.011676
PubMed Web of Science® Google Scholar
23Aaronson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993; 85(5): 365-376.
10.1093/jnci/85.5.365
CAS PubMed Web of Science® Google Scholar
24Groenvold M, Klee MC, Sprangers MA, Aaronson NK. Validation of the EORTC QLQ-C30 quality of life questionnaire through combined qualitative and quantitative assessment of patient-observer agreement. J Clin Epidemiol. 1997; 50(4): 441-450.
10.1016/S0895-4356(96)00428-3
CAS PubMed Web of Science® Google Scholar
25Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998; 16(1): 139-144.
10.1200/JCO.1998.16.1.139
CAS PubMed Web of Science® Google Scholar
26Ringash J, O'Sullivan B, Bezjak A, Redelmeier DA. Interpreting clinically significant changes in patient-reported outcomes. Cancer. 2007; 110(1): 196-202.
10.1002/cncr.22799
CAS PubMed Web of Science® Google Scholar
27Ercolani G, Grazi GL, Ravaioli M, et al. Liver resection for multiple colorectal metastases: influence of parenchymal involvement and total tumor volume, vs number or location, on long-term survival. Arch Surg. 2002; 137(10): 1187-1192.
10.1001/archsurg.137.10.1187
PubMed Google Scholar
28Capussotti L, Ferrero A, Vigano L, Ribero D, Lo Tesoriere R, Polastri R. Major liver resections synchronous with colorectal surgery. Ann Surg Oncol. 2007; 14(1): 195-201.
10.1245/s10434-006-9055-3
PubMed Web of Science® Google Scholar
29Wei AC, Coburn NG, Moulton C, et al. A phase II multicenter study of metastasectomy of intra- and extra-hepatic metastases from colorectal cancer. J Clin Oncol. 2013; 31(suppl 4): 482.
10.1200/jco.2013.31.4_suppl.482
PubMed Web of Science® Google Scholar
30Griffiths C, Bogach J, Simunovic M, et al. Simultaneous resection of colorectal cancer with synchronous liver metastases; a practice survey. HPB. 2020; 22(5): 728-734.
10.1016/j.hpb.2019.09.012
PubMed Web of Science® Google Scholar

Citing Literature

Volume125, Issue4

March 15, 2022

Pages 671-677

Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial

Abstract

Background and Objectives

Methods

Results

Conclusion

Open Research

DATA AVAILABILITY STATEMENT

Supporting Information

REFERENCES

Citing Literature

References

Information

About Wiley Online Library

Help & Support

Opportunities

Connect with Wiley

Simultaneous resection for synchronous colorectal cancer liver metastases: A feasibility clinical trial

Abstract

Background and Objectives

Methods

Results

Conclusion

Open Research

DATA AVAILABILITY STATEMENT

Supporting Information

REFERENCES

Citing Literature

References

Related

Information