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

Fretland ÅA, Kazaryan AM, Bjørnbeth BA, Flatmark K, Andersen MH, Tønnessen TI, Bjørnelv GM, Fagerland MW, Kristiansen R, Øyri K, Edwin B - Trials (2015)

Bottom Line: A biobank of liver and tumor tissue will be established and molecular analysis will be performed.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.

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus

Oslo-CoMet study: overview of substudies and translational research. SF-36, Short Form 36; FDG-PET, fludeoxyglucose positron emission tomography; CT, Computed Tomography.
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Related In: Results  -  Collection

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Fig2: Oslo-CoMet study: overview of substudies and translational research. SF-36, Short Form 36; FDG-PET, fludeoxyglucose positron emission tomography; CT, Computed Tomography.

Mentions: The case report form (CRF) for each patient in the study will be implemented as an XML document which will be stored in a database. When changes are made on a CRF, a copy of the old CRF will be stored together with a log showing who made the changes. Users will not have access to the CRF log. For security reasons there will be one main copy of the database with full patient identification, and two copies with modifications: one anonymized database, and one with de-identified information. Analysis will never be performed on the main database (Figure 2).Figure 2


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

Fretland ÅA, Kazaryan AM, Bjørnbeth BA, Flatmark K, Andersen MH, Tønnessen TI, Bjørnelv GM, Fagerland MW, Kristiansen R, Øyri K, Edwin B - Trials (2015)

Oslo-CoMet study: overview of substudies and translational research. SF-36, Short Form 36; FDG-PET, fludeoxyglucose positron emission tomography; CT, Computed Tomography.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4358911&req=5

Fig2: Oslo-CoMet study: overview of substudies and translational research. SF-36, Short Form 36; FDG-PET, fludeoxyglucose positron emission tomography; CT, Computed Tomography.
Mentions: The case report form (CRF) for each patient in the study will be implemented as an XML document which will be stored in a database. When changes are made on a CRF, a copy of the old CRF will be stored together with a log showing who made the changes. Users will not have access to the CRF log. For security reasons there will be one main copy of the database with full patient identification, and two copies with modifications: one anonymized database, and one with de-identified information. Analysis will never be performed on the main database (Figure 2).Figure 2

Bottom Line: A biobank of liver and tumor tissue will be established and molecular analysis will be performed.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.

View Article: PubMed Central - PubMed

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.

No MeSH data available.


Related in: MedlinePlus