; for the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group IMPORTANCE Laparoscopic distal gastrectomy is gaining popularity over open distal gastrectomy for gastric cancer because of better early postoperative outcomes. However, to our knowledge, no studies have proved whether laparoscopic distal gastrectomy is oncologically equivalent to open distal gastrectomy. OBJECTIVE To examine whether the long-term survival among patients with stage I gastric cancer undergoing laparoscopic distal gastrectomy is noninferior to that among patients undergoing open distal gastrectomy. DESIGN The Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group, which includes 15 surgeons from 13 institutes, conducted a phase 3, multicenter, open-label, noninferiority, prospective randomized clinical trial (KLASS-01) of patients with histologically proven, preoperative clinical stage I gastric adenocarcinoma from January 5, 2006, to August 23, 2010. Survival and recurrence status of the patients was determined in December 2016. INTERVENTIONS Patients were randomly assigned (1:1) to laparoscopic distal gastrectomy (n = 705) or open distal gastrectomy (n = 711). Of these patients, 85 received a surgical approach opposite the one to which they were randomized (63 randomized to the open surgery group and 22 to the laparoscopic group). MAIN OUTCOMES AND MEASURES Difference in 5-year overall survival between the laparoscopic and open distal gastrectomy groups. The noninferiority margin was prespecified as −5% (corresponding hazard ratio of 1.54), with an assumed survival of 90% after 5 years in the open surgery group. RESULTS Among the 1416 patients (mean [SD] age, 57.3 [11.1] years; 940 [66.4%] male) included in the study, the 5-year overall survival rates were 94.2% in the laparoscopic group and 93.3% in the open surgery group (log-rank P = .64). Intention-to-treat analysis confirmed the noninferiority of the laparoscopic approach compared with the open approach (difference, 0.9 percentage points; 1-sided 97.5% CI, −1.6 to infinity). The 5-year cancer-specific survival rates were similar between the 2 groups (97.1% in the laparoscopic group and 97.2% in the open surgery group, log-rank P = .91; difference, −0.03 percentage points; 1-sided 97.5% CI, −1.8 to infinity). Per-protocol analysis results were consistent with the intention-to-treat results for overall and cancer-specific survival rates. CONCLUSIONS AND RELEVANCE The KLASS-01 trial revealed similar overall and cancer-specific survival rates between patients receiving laparoscopic and open distal gastrectomy. Laparoscopic distal gastrectomy is an oncologically safe alternative to open surgery for stage I gastric cancer.

The long-term oncologic outcomes of laparoscopic gastrectomy for patients with gastric cancer were comparable to those of open gastrectomy in a large-scale, multicenter, retrospective clinical study.

The results suggest that the elevated preoperative N/L ratio predicts poor disease-free and overall survival following resection for late stage gastric cancer. It may be utilized as a simple, reliable prognostic factor for risk stratification and will provide better treatment allocation.

Background: The aim of this multicenter retrospective study was to establish background data for future randomized clinical trial comparing open and laparoscopy-assisted gastrectomies (LAGs). We sought to evaluate the technical feasibility of LAG by determining the morbidity and mortality and identifying corresponding predictive factors.Patients and Methods: A retrospective multicenter study was carried out in Korea on 1,485 patients in who, LAG had been attempted for gastric cancer under the care of ten surgeons, at ten institutions, during the period spanning May 1998 to December 2005. Patient characteristics, operative outcomes, and postoperative morbidities and mortalities were analyzed.Results: Overall morbidity and mortality rates were 14.0% and 0.6%, respectively. Complications included: wound problem (4.2%, n = 62), intraluminal bleeding (1.3%, n = 20), intra-abdominal abscess or fluid collection (1.3%, n = 19), anastomotic leakage (1.3%, n = 18), and intra-abdominal bleeding (1.3%, n = 18). By using multivariate analysis we found that the two most important risk factors associated with postoperative complications were presence of comorbidity in the patient and lack of experience on the part of the surgeon.Conclusion: LAG is a technically feasible, safe, and effective method for treating patients with gastric cancer. Extra caution in patients with comorbidities, and dedication to improving surgical proficiency in LAG, may decrease the risk of complications. Through this study, we have established the inclusion criteria for LAG. For our multicenter, prospective, randomized trials

The long-term survival outcome rates of LAG for AGC in the present study were comparable to those previously reported for open gastrectomy. Based on the present results, a well-designed phase III trial comparing LAG and open gastrectomy for AGC will be needed to affirm the validity of LAG for AGC.

Patients with SRC histology do not have a worse prognosis than patients with other types of gastric carcinoma.

Young patients with gastric carcinoma do not have a worse prognosis than older patients. The important prognostic factor was whether the patients underwent curative resection.

A randomized controlled trial to evaluate the long-term outcomes of laparoscopic distal gastrectomy for gastric cancer is currently ongoing in Korea. Patients with cT1N0M0-cT2aN0M0 (American Joint Committee on Cancer, 6th edition) distal gastric cancer were randomized to receive either laparoscopic or open distal gastrectomy. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 cases each of laparoscopy-assisted distal gastrectomy and open distal gastrectomy and their institutions should have performed more than 80 cases each of both procedures each year. Fifteen surgeons from 12 institutions recruited 1,415 patients. The primary endpoint is overall survival. The secondary endpoints are disease-free survival, morbidity, mortality, quality of life, inflammatory and immune responses, and cost-effectiveness (ClinicalTrials.gov ID: NCT00452751).