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

Abstract

BackgroundLaparoscopic 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/DesignThe 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.DiscussionAfter 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 registrationThe trial was registered in ClinicalTrals.gov (NCT01516710) on 19 January 2012.

Impact of totally laparoscopic combined management of colorectal cancer with synchronous hepatic metastases on severity of complications: a propensity-score-based analysis

“…The advantages of laparoscopy over open surgery have been high lightened in many series, in the setting of both isolated colorectal [12][13][14][15] and hepatic resections [16][17][18][19][20]. Furthermore, more recently even safety and efficacy of combined resections have been reported [7][8][9][10][11], with shorter length of stay and reduced morbidity compared with staged approaches if performed in a selected population of patients [6][7][8].…”

“…The lower risk and In the present study, the laparoscopic approach was associated with longer operative time compared with open surgery (420 vs 310 min, respectively; p = 0.03), even though both colorectal and hepatic teams had already completed the learning curve once TLA was adopted at our institution: Longer length of surgery seemed not to have affected clinical outcome in terms of blood loss, functional recovery and morbidity. The laparoscopic hepatic resection was generally performed before colorectal resection: Indeed, the conversion rate in hepatic surgery is still higher compared to colorectal surgery [12][13][14][15][16][17][18][19][20], and a change in strategy could be required in this circumstance; secondly, preliminary liver exploration with lesions mapping may lead to re-assessment of the approach from combined to staged (eventually liver-first [26]). Conversion rate was low (one patient) due to a limited number of major hepatectomies and resections for lesions in posterosuperior segments, reflecting an initially cautious policy of indication to TLA.…”

“…Patients with resectable hepatic recurrences can be operated on again by laparoscopy, since previous TLA facilitates access to hepatic area due to low extent of adhesions [17][18][19][20]44].…”

“…Moreover, technological advances and acquirement of adequate surgical expertise lead to widespread diffusion of minimally invasive approaches, both for primary CRC [12][13][14][15] and for liver metastases [16][17][18][19][20]: At the same time, even patients' awareness about benefits of laparoscopy (better postoperative pain control, earlier return to autonomous self-care and superior cosmetic result) has increased and contributed to its success. In this setting, the possibility of a totally laparoscopic approach (TLA) in combined resection of primary cancer and resectable SCLM represents an attracting option, possibly reducing complications correlated with extended laparotomy and with enhanced biological stress.…”

Laparoskopska resekcija jeter zaradi zasevkov raka debelega črevesa in danke – rezultati zdravljenja

“…Presumably, it is consequence of less extensive stress response of organism (25). The results of the first prospective randomised controlled trial (The OsloCoMet Study) comparing LLRs vs. open procedures will be published soon (26). This well designed study will certainly have adequate statistical power, and hopefully the question of whether LLRs are better from open procedures will be finally answered.…”