Long-Term Outcomes of Laparoscopic Distal Gastrectomy for Locally Advanced Gastric Cancer: The KLASS-02-RCT Randomized Clinical Trial

Abstract

PURPOSE It is unclear whether laparoscopic distal gastrectomy for locally advanced gastric cancer is oncologically equivalent to open distal gastrectomy. The noninferiority of laparoscopic subtotal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer compared with open surgery in terms of 3-year relapse-free survival rate was evaluated. PATIENTS AND METHODS A phase III, open-label, randomized controlled trial was conducted for patients with histologically proven locally advanced gastric adenocarcinoma suitable for distal subtotal gastrectomy. The primary end point was the 3-year relapse-free survival rate; the upper limit of the hazard ratio (HR) for noninferiority was 1.43 between the laparoscopic and open distal gastrectomy groups. RESULTS From November 2011 to April 2015, 1,050 patients were randomly assigned to laparoscopy (n = 524) or open surgery (n = 526). After exclusions, 492 patients underwent laparoscopic surgery and 482 underwent open surgery and were included in the analysis. The laparoscopy group, compared with the open surgery group, suffered fewer early complications (15.7% v 23.4%, respectively; P = .0027) and late complications (4.7% v 9.5%, respectively; P = .0038), particularly intestinal obstruction (2.0% v 4.4%, respectively; P = .0447). The 3-year relapse-free survival rate was 80.3% (95% CI, 76.0% to 85.0%) for the laparoscopy group and 81.3% (95% CI, 77.0% to 85.0%; log-rank P = .726) for the open group. Cox regression analysis after stratification by the surgeon revealed an HR of 1.035 (95% CI, 0.762 to 1.406; log-rank P = .827; P for noninferiority = .039). When stratified by pathologic stage, the HR was 1.020 (95% CI, 0.751 to 1.385; log-rank P = .900; P for noninferiority = .030). CONCLUSION Laparoscopic distal gastrectomy with D2 lymphadenectomy was comparable to open surgery in terms of relapse-free survival for patients with locally advanced gastric cancer. Laparoscopic distal gastrectomy with D2 lymphadenectomy could be a potential standard treatment option for locally advanced gastric cancer.

The 140 years' journey of gastric cancer surgery: From the two hands of Billroth to the multiple hands of the robot

“…Phase III clinical trials were conducted in Japan, South Korea, and China to examine the noninferiority of LDG to ODG for advanced gastric cancer. [34][35][36] The result of the primary analysis was first reported in the CLASS01 trial performed in China, which proved the noninferiority of LDG to ODG. Noninferiority was confirmed using the point estimation of 3-year relapse-free survival.…”

“…On the other hand, LG for advanced gastric cancer has been considered to require further examination from the viewpoints of tumor handling, accuracy of D2 lymph node dissection, and safety. Phase III clinical trials were conducted in Japan, South Korea, and China to examine the noninferiority of LDG to ODG for advanced gastric cancer 34‐36 . The result of the primary analysis was first reported in the CLASS01 trial performed in China, which proved the noninferiority of LDG to ODG.…”

Single-incision laparoscopic antrectomy for type I gastric neuroendocrine tumor: a case report

“…SILS offers excellent cosmetic results because scarring is concealed in the umbilicus. There are a number of risks related to surgery, however, such as anastomotic leakage, delayed gastric emptying and intraabdominal abscesses [7,8]. There may also be short or long term decline in nutritional status.…”

Everything, in Retrospect, is Obvious

“…There are RCTs from Korea demonstrating the oncologic equivalency of laparoscopic and open distal gastrectomy, although most focus on early gastric cancer and exclude patients undergoing total gastrectomy. 3 Due to the well-established differences in tumor biology and adverse prognostic factors between gastric adenocarcinoma from Eastern and Western countries, I will limit the discussion to the one Western RCT available. 4 In the Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA) trial, investigators from ten experienced upper gastrointestinal centers in the Netherlands reported short-term outcomes of 227 patients.…”