BACKGROUND The oncological efficacy and safety of laparoscopic gastrectomy are under debate for the Western population with predominantly advanced gastric cancer undergoing multimodality treatment. METHODS In 10 experienced upper GI centers in the Netherlands, patients with resectable (cT1-4aN0-3bM0) gastric adenocarcinoma were randomly assigned to either laparoscopic or open gastrectomy. No masking was performed. The primary outcome was hospital stay. Analyses were performed by intention to treat. It was hypothesized that laparoscopic gastrectomy leads to shorter hospital stay, less postoperative complications, and equal oncological outcomes. RESULTS Between 2015 and 2018, a total of 227 patients were randomly assigned to laparoscopic (n = 115) or open gastrectomy (n = 112). Preoperative chemotherapy was administered to 77 patients (67%) in the laparoscopic group and 87 patients (78%) in the open group. Median hospital stay was 7 days (interquartile range, 5-9) in both groups ( P = .34). Median blood loss was less in the laparoscopic group (150 v 300 mL, P < .001), whereas mean operating time was longer (216 v 182 minutes, P < .001). Both groups did not differ regarding postoperative complications (44% v 42%, P = .91), in-hospital mortality (4% v 7%, P = .40), 30-day readmission rate (9.6% v 9.1%, P = 1.00), R0 resection rate (95% v 95%, P = 1.00), median lymph node yield (29 v 29 nodes, P = .49), 1-year overall survival (76% v 78%, P = .74), and global health-related quality of life up to 1 year postoperatively (mean differences between + 1.5 and + 3.6 on a 1-100 scale; 95% CIs include zero). CONCLUSION Laparoscopic gastrectomy did not lead to a shorter hospital stay in this Western multicenter randomized trial of patients with predominantly advanced gastric cancer. Postoperative complications and oncological efficacy did not differ between laparoscopic gastrectomy and open gastrectomy.

BackgroundFor gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy.MethodsThe study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness.DiscussionIn this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5 years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.Trial registration NCT02248519

Gastric cancer is the fifth most common malignancy in the world, with nearly one million new cases of gastric cancer diagnosed every year. 1 Curative treatment of gastric adenocarcinoma consists of partial or total resection of the stomach combined with lymphadenectomy. 2 Over the last years, multimodality treatment strategies such as neoadjuvant chemo(radio)therapy, perioperative chemotherapy and adjuvant chemotherapy have gained importance in the treatment of gastric cancer by improving the likelihood of a radical tumor resection, disease free survival and overall survival. 3-8 Unfortunately, the overall 5 year survival rate still remains poor (35-45%). 4,9 Accurate staging of gastric cancer allows for selection of the most appropriate therapy, minimizes unnecessary surgery and maximizes the likelihood of benefit from the selected treatment. After initial diagnosis by gastroscopy with tumor biopsy, diagnostic work-up can consist of endoscopic ultrasonography (EUS), computed tomography (CT) and 18 F-fluorodeoxyglucose positron emission tomography (18 F-FDG PET). However, these techniques all have their limitations. EUS is an invasive, highly operator-dependent technique and does not detect distant metastases. 10,11 CT exposes patients to ionizing radiation and has poor soft-tissue contrast. 18 F-FDG PET is impaired by the fact that not all gastric carcinomas are 18 F-FDG-avid (avidity ranging from 42-96%) and has a low spatial resolution. 12 Historically, the role of magnetic resonance imaging (MRI) in gastric cancer has been limited, since relatively long acquisition times and technical challenges of peristaltic motion and respiration artifacts resulted in poor imaging quality. 13,14 With the continuous technical improvements in MRI scanning, including fast imaging techniques, (respiratory) motion compensation techniques, use of anti peristaltic agents and the introduction of functional MRI