Effect of Laparoscopic Distal Gastrectomy vs Open Distal Gastrectomy on Long-term Survival Among Patients With Stage I Gastric Cancer

Abstract

; 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.

Oncological feasibility of laparoscopic subtotal gastrectomy compared with laparoscopic proximal or total gastrectomy for cT1N0M0 gastric cancer in the upper gastric body

“…The oncological feasibility of these procedures contains the feasibility of laparoscopic gastrectomy and that of subtotal, proximal or total gastrectomy for cT1N0M0 gastric cancer in the upper gastric body. Recently, a pivotal phase III clinical trial in Korea: the KLASS-01 demonstrated the oncological feasibility of laparoscopic distal gastrectomy for stage I gastric cancer [25]. As the KLASS-01 result can be extrapolated to other types of laparoscopic gastrectomies, the favorable survival outcomes in our study may present the oncological feasibility of subtotal, proximal or total gastrectomy for cT1N0M0 gastric cancer in the upper gastric body.…”

Effect of Laparoscopic vs Open Distal Gastrectomy on 3-Year Disease-Free Survival in Patients With Locally Advanced Gastric Cancer

“…8,14 Compared with open gastrectomy, laparoscopic gastrectomy has been shown to have lower rates of intraoperative and postoperative morbidity as well as faster recovery. 8,14 The safety and efficacy of laparoscopic distal gastrectomy for stage I gastric cancer has recently been confirmed by a Korean randomized trial, which showed decreased morbidity 5 and noninferior 5-year overall survival 15 of the laparoscopic approach compared with the open approach. However, in the context of early-stage gastric cancer, a D2 lymphadenectomy is not necessarily required and there has been uncertainty about the balance of risks and benefits for laparoscopic approaches when D2 resection is indicated to remove all potentially malignant lymph nodes.…”

Multi‐institutional analysis of the prognostic significance of postoperative complications after curative resection for gastric cancer

“…Gastrectomy with systematic lymphadenectomy remains the backbone of curative treatment of patients who were present with resectable gastric cancer. 1,2 Despite the recent advances in imaging, surgical devices, and perioperative management, morbidity rate after gastrectomy is reportedly 20%-30%. 3,4 Incidence of postoperative complications invariably contributes to a longer hospitalization, increased medical costs, and diminished quality of life.…”