Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Mar 4:16:73.
doi: 10.1186/s13063-015-0577-5.

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
Randomized Controlled Trial

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

Åsmund Avdem Fretland et al. Trials. .

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.

PubMed Disclaimer

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.
See this image and copyright information in PMC

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. - DOI - PubMed
    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. - DOI - PubMed
    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. - DOI - PMC - PubMed
    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. - DOI - PMC - PubMed
    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. - DOI - PubMed

Publication types

MeSH terms

Associated data