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.

Robotic gastrectomy for the treatment of gastric cancer is a feasible and safe procedure in the hands of experienced laparoscopic surgeons. Robotic gastrectomy offers better short-term surgical outcomes than the open and laparoscopic methods. Furthermore, this procedure may be a preferable alternative for the treatment of gastric cancer.

Based on operative time analysis, this study show that experience of 50 cases of LADG with systemic lymphadenectomy for early gastric cancer is required to achieve optimum proficiency.

Background. The risk of recurrence and recurrence patterns after laparoscopy-assisted gastrectomy for gastric cancer remain unclear. The objective of this study is to assess recurrence and its timing, patterns, and risk factors following laparoscopy-assisted gastrectomy from multicenter data. Methods. A retrospective multicenter study was performed using data from 1,485 patients who had undergone laparoscopy-assisted gastrectomy for gastric cancer at ten institutions from 1998 to 2005. Recurrence and its timing and patterns were reviewed. Univariate and multivariate analyses were performed to identify risk factors for recurrence. Results. Excluding 68 patients (9 postoperative mortalities, 1 synchronous distant metastasis, 2 nonadenocarcinomas, and 56 losses to follow-up), 50 of 1,417 patients (3.5%) had recurrences. Incidence of recurrence was 1.6% (19/1186) in early gastric cancer and 13.4% (31/231) in advanced gastric cancer. Recurrence occurred in 34 of 50 patients (68.0%) within 2 years of surgery, and in 45 of 50 patients (90.0%) within 3 years. The recurrence pattern was hematogenous in 17 patients (34.0%), peritoneal in 11 (22.0%), locoregional in 10 (20.0%), distant lymph nodes in 2 (4.0%), and mixed in 10 (20.0%). Advanced T-classification and lymph node metastases were risk factors for recurrence. Conclusions. Laparoscopy-assisted gastrectomy showed satisfactory long-term oncologic outcomes similar to those of open surgery. The study provides additional evidence suggesting that laparoscopy-assisted gastrectomy is a good alternative to open gastrectomy in patients with gastric cancer of relatively early stage, although results of a randomized controlled trial and more long-term follow-up are needed to provide conclusive evidence.

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).

PurposeCurative surgery for patients with advanced or even early gastric cancer can be defined as resection of the stomach and dissection of the first and second level lymph nodes, including the greater omentum. The aim of this study was to evaluate the short- and long- term outcomes of partial omentectomy (PO) as compared with complete omentectomy (CO).Materials and MethodsSeventeen consecutive open distal gastrectomies with POs were initially performed between February and July in 2006. The patients' clinicopathologic data and post-operative outcomes were retrospectively compared with 20 patients who underwent open distal gastrectomies with COs for early gastric cancer in 2005.ResultsThe operation time in PO group was significantly shorter than that in CO group (142.4 minutes vs. 165.0 minutes, p=0.018). The serum albumin concentration on the first post-operative day in PO group was significantly higher than CO group (3.8 g/dL vs. 3.5 g/dL, p=0.018). Three postoperative minor complications were successfully managed with conservative treatment. Median follow-up period between PO and CO was 38.1 and 37.7 months. All patients were alive without recurrence until December 30, 2009.ConclusionPO during open radical distal gastrectomy can be considered a more useful procedure than CO for treating early gastric cancer. To document the long-term technical and oncologic safety of this procedure, a large-scale prospective randomized trial will be needed.

Background Since reconstruction after laparoscopyassisted distal gastrectomy (LADG) is performed through a small minilaparotomy window, the clinical course and complication rate are influenced by clinical technical expertise and experience. The aim of this study was to compare postoperative complications and survival rates of Billroth I and Billroth II reconstructions after LADG. Patients and methods We retrospectively collected data from 1,259 patients who underwent LADG performed by ten surgeons at ten hospitals between April 1998 and December 2005. Patients were classified into two groups according to reconstruction method used: the Billroth I group (n = 875) and the Billroth II group (n = 384). Patient and tumor characteristics, operative details, and postoperative complications were analyzed.Results Billroth II reconstruction was performed on obese patients (p = 0.003) and patients with more advanced tumors (p \ 0.001). Billroth I reconstruction was performed more frequently in the lower portion of the stomach (p \ 0.001) and yielded shorter operating times. The postoperative complication rate was 11.4% in the Billroth I group, which was lower than that in the Billroth II group (16.9%) (p = 0.011). However, the differences in the major complication rates were not statistically significant (p = 0.263). Of the intra-abdominal complications, intraluminal or intraperitoneal bleeding was the most frequent complication in the Billroth I group and duodenal stump leakage was the most frequent in the Billroth II group. The postoperative mortality rate did not show a statistically significant difference.

BackgroundExtended systemic lymphadenectomy (D2) is standard procedure for surgical treatment of advanced gastric cancer (AGC) although less extensive lymphadenectomy (D1) can be applied to early gastric cancer. Complete D2 lymphadenectomy is the mandatory procedure for studies that evaluate surgical treatment results of AGC. However, the actual extent of D2 lymphadenectomy varies among surgeons because of a lacking consensus on the anatomical definition of each lymph node station. This study is aimed to develop a consensus for D2 lymphadenectomy and also to qualify surgeons that can perform both laparoscopic and open D2 gastrectomy.Methods/DesignThis (KLASS-02-QC) is a prospective, observational, multicenter study to qualify the surgeons that will participate in the KLASS-02-RCT, which is a prospective, randomized, clinical trial comparing laparoscopic and open gastrectomy for AGC. Surgeons and reviewers participating in the study will be required to complete a questionnaire detailing their professional experience and specific gastrectomy surgical background/training, and the gastrectomy metrics of their primary hospitals. All surgeons must submit three laparoscopic and three open D2 gastrectomy videos, respectively. Each video will be allocated to five peer reviewers; thus each surgeon’s operations will be assessed by a total of 30 reviews. Based on blinded assessment of unedited videos by experts’ review, a separate review evaluation committee will decide whether or not the evaluated surgeon will participate in the KLASS-02-RCT. The primary outcome measure is each surgeon’s proficiency, as assessed by the reviewers based on evaluation criteria for completeness of D2 lymphadenectomy.DiscussionWe believe that our study for standardization of D2 lymphadenectomy and surgical quality control (KLASS-02-QC) will guarantee successful implementation of the subsequent KLASS-02-RCT study. After making consensus on D2 lymphadenectomy, we developed evaluation criteria for completeness of D2 lymphadenectomy. We also developed a unique surgical standardization and quality control system that consists of recording unedited surgical videos, and expert review according to evaluation criteria for completeness of D2 lymphadenectomy. We hope our systematic approach will set a milestone in surgical standardization that is essential for surgical clinical trials. Additionally, our methods will serve as a novel system for educating surgeons and assessing surgical proficiency.Trial registrationNCT01283893.