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

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

SUBMITTER: Fretland AA

PROVIDER: S-EPMC4358911 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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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 Åsmund Avdem ÅA Kazaryan Airazat M AM Bjørnbeth Bjørn Atle BA Flatmark Kjersti K Andersen Marit Helen MH Tønnessen Tor Inge TI Bjørnelv Gudrun Maria Waaler GM Fagerland Morten Wang MW Kristiansen Ronny R Øyri Karl K Edwin Bjørn B

Trials 20150304

<h4>Background</h4>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.<h4>Methods/design</h4>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 (overa ...[more]

PMID: 25872027

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Project description:ImportanceSurgery represents the mainstay treatment of colorectal liver metastases. Indications for the laparoscopic approach in this setting have been widened and there is a need to confirm the benefits of minimally invasive liver surgery (MILS) in patients with complex disease states.ObjectiveTo compare outcomes of laparoscopic surgery with those of open surgery for liver metastases from colorectal cancer, focusing on the characteristics of modern MILS and therefore overcoming possible selection bias related to different policies for patients' eligibility for MILS over time.Design, setting, and participantsA cohort study of 885 resections performed for liver metastases from colorectal cancer between January 1, 2004, and June 30, 2017, at the Hepatobiliary Surgery Unit of San Raffaele Hospital, Milano, Italy, comprising 187 laparoscopic and 698 open resections. Procedures performed using the MILS approach with a ratio of MILS to total resections per year of more than 30% were considered and were matched by propensity scores (ratio of 1:4) to procedures performed using the open approach with a ratio of MILS to total resections per year of less than 30%.Main outcomes and measuresThe primary end point was short-term outcomes, including morbidity, mortality, functional recovery, and interval between surgery and adjuvant treatments; the secondary end point was long-term outcomes.ResultsAmong this cohort (104 patients in the MILS group; 46 women and 58 men; median age, 62 years [range, 35-81 years]; and 412 patients in the open group; 181 women and 231 men; median age, 60 years [range, 37-80 years]), primary end-point data showed a significantly higher incidence of postoperative morbidity in patients who underwent open resections compared with those who underwent MILS (94 [22.8%] vs 21 [20.2%]; P?=?.04). Patients in the MILS group had fewer major complications (Dindo-Clavien grades III-V) compared with patients in the open group (Dindo-Clavien grades III-V; 7 [6.7%] vs 35 [8.5%]; P?=?.03) as well as shorter lengths of stay (median [range] duration, 3 [2-35] vs 5 [4-37] days; P?=?.02). Oncologic results were not compromised by the laparoscopic approach.Conclusions and relevanceIn this study, the results of the propensity score matching analysis between modern laparoscopic surgery and previous open surgery appear to confer more comparable cohorts for complexity, further supporting the advantages of laparoscopy in the surgical treatment of liver metastases from colorectal cancer. The increase in use that laparoscopy has experienced appears to be based on increased feasibility, widening of eligibility criteria for patients, enhanced clinical effectiveness, and oncologic outcomes. All these elements together suggest that up to 70% of patients appear to be candidates for this minimally invasive surgical approach in high-volume centers.

Project description:BackgroundThe objective of this study was to compare the results of laparoscopic hepatectomy with those of open hepatectomy for colorectal cancer liver metastases (CCLM) using a propensity score matching (PSM) in two university hospital settings.MethodsA patient in the laparoscopic approach (LA) surgery group was randomly matched with another patient in the open approach (OA) group using a 1:1 allocated ratio with the nearest estimated propensity score. No patients of the LA group were excluded for the matching. Matching criteria included age, gender, body mass index (BMI), American society anesthesiologists score, potential co-morbidities, hepatopathies, synchronous or metachronous lesions, size and number of CCLM, preoperative chemotherapy, minor or major liver resections. Intraoperative, postoperative data, and survival were compared in both groups.ResultsFrom January 2012 to January 2015, a total of 242 hepatectomies were consecutively performed, of which 119 for CCLM, namely 101 in the OA group (84.9%) and 18 in the LA group (15.1%). The conversion rate was 5.6% (n=1). The mortality rate was 1% in the OA group and 0% in the LA group. Prior to PSM, there was a statistically significant difference favorable to the LA group regarding operative time, blood loss, length of hospital stay and the rate of medical complications. After PSM, there was no difference regarding operative time or length of hospital stay. However, there was a trend towards less blood loss (P=0.066) and fewer medical complications (44.4% vs.16.7%, P=0.07). The R0 resection rate was 94.4% (n=17) in the two groups. In addition, there was no difference regarding overall survival (P=0.358) and recurrence-free survival [HR =0.99 (0.1-12.7); P=0.99].ConclusionsLaparoscopic liver resections for CCLM seem to yield short- and long-term results, which are similar to open hepatectomies, and could well be considered an alternative to open surgery and become the gold standard in carefully selected patients.

Dataset Information

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

Publications

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

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