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OBJECTIVE To qualify surgeons to participate in a randomized trial comparing laparoscopic and open distal D2 gastrectomy for advanced gastric cancer. SUMMARY OF BACKGROUND DATA No studies have sought to qualify surgeons for a randomized trial comparing laparoscopic and open D2 gastrectomy for advanced gastric cancer. METHODS We conducted a multicenter prospective observational study evaluating unedited videos of laparoscopic and open D2 gastrectomy performed by 27 surgeons. Surgeons performed 3 of each laparoscopic and open distal gastrectomies with D2 lymphadenectomy for gastric cancer. Five peers reviewed each unedited video using a video assessment form. Based on experts' review of videos, a separate review committee decided surgeons as "Qualified" or "Not-qualified." RESULTS Twelve surgeons (44.4%) were qualified on initial evaluation whereas the other 15 surgeons were not. Another 9 surgeons were finally qualified after re-evaluation. The median score for Qualified was significantly higher than Not-qualified (P < 0.001).Significant differences between Qualified and Not-qualified were noted both in operation type and in all evaluation area of surgical skill, perigastric, and extra-perigastric lymphadenectomy, although the inter-rater variability of the assessment score was low (kappa = 0.285). However, Not-qualified surgeons' scores improved upon re-evaluation of resubmitted videos.When compared laparoscopy with open surgery, median scores were similar between the 2 groups (P = 0.680). However, open gastrectomy scores for surgical skills were significantly higher than for laparoscopic surgery (P = 0.016). CONCLUSIONS Our surgeon quality control study for gastrectomy represents a milestone in surgical standardization for surgical clinical trials. Our methods could also serve as a system for educating surgeons and assessing surgical proficiency.

The aim of the study was to evaluate the short-term outcomes of KLASS-02-RCT, a multicenter randomized controlled trial comparing laparoscopic distal gastrectomy (LDG) with D2 lymphadenectomy with open distal gastrectomy (ODG).Although several benefits of laparoscopic gastric cancer surgery have been reported, strong evidence is still limited, especially in locally advanced gastric cancer which requires extensive lymph node dissection.Enrollment criteria included histologically confirmed cT2-4a and N0-1 gastric adenocarcinoma. Thirty-day morbidity, 90-day mortality, postoperative pain, and recovery were compared between LDG and ODG groups.A total of 1050 patients were randomly assigned to LDG (n = 526) or ODG group (n = 524) between November 2011 and April 2015. After excluding patients who received bypass or no surgery, 1011 patients were analyzed as actual treatment group. Mean number of totally retrieved lymph nodes was similar in both groups (LDG = 46.6 vs ODG = 47.4, P = 0.451). Early morbidity rate was significantly lower after LDG (16.6%) than after ODG (24.1%; P = 0.003). Postoperative analgesics use and patients' reported pain score were significantly lower after LDG. First day of flatus was earlier after LDG (3.5 vs 3.7 d, P = 0.025) and postoperative hospital stay was shorter in LDG group (8.1 vs 9.3 d, P = 0.005). Ninety days' mortality rate was similar in both groups (LDG = 0.4% vs ODG = 0.6%, P = 0.682).Laparoscopic distal gastrectomy with D2 lymphadenectomy for locally advanced gastric cancer shows benefits in terms of lower complication rate, faster recovery, and less pain compared with open surgery.

Enhanced recovery after surgery (ERAS) programs have gained widespread acceptance in different fields of major surgery. However, most elements of perioperative care in ERAS are based on practices that originated from colorectal surgery. This study investigated compliance with the main elements of ERAS for patients undergoing gastrectomy for gastric carcinoma. This phase 2 study enrolled 168 patients undergoing elective gastrectomy for gastric carcinoma. An ERAS program consisting of 18 main elements was implemented, and compliance with each element was evaluated (ClinicalTrials.gov, NCT01653496). Distal gastrectomy was performed for 142 patients (84.5%) and total gastrectomy for 26 patients (10.1%). Laparoscopic surgery was performed for 141 patients (86%). The postoperative morbidity rate was 9.5%, and the mortality rate was 0%. The rates of compliance with the 18 main elements of ERAS ranged from 88.1 to 100%. The lowest compliance rate was observed in the restriction of intravenous fluid element (88.1%). Overall, all ERAS elements were successfully applied for 122 patients (72.6%). In the multivariate analysis, the significant factors that adversely affected compliance with ERAS were surgery during the early study period [odds ratio (OR) 0.39; p = 0.038], open surgery (OR 0.15; p

Knowledge of the intraoperative location of lesions is a prerequisite for deciding the proper extent of gastric resection or the choice of anastomosis technique during totally laparoscopic distal gastrectomy (TLDG) for early gastric cancer (EGC). In this study we introduce a novel tumor localization method for TLDG: endoscopic blood tattooing.Twenty-three consecutive patients scheduled for TLDG for EGC were enrolled in this prospective study. The day before surgery, 2-3 ml of autologous blood was injected into the gastric muscle layer at 3-4 cm proximal to the lesion during endoscopy.The study subjects consisted of 15 males and 8 females with a mean age of 61 ± 10.4 years. During surgery, the endoscopic blood tattooed sites were successfully identified in all 23 patients. No complications associated with the procedure occurred, and no patient had microscopic residual tumor cells at the proximal resection margin, with a mean proximal margin length of 3.3 ± 2.7 cm. Eighteen patients underwent TLDG with Billroth II anastomosis, four patients with Roux-en-Y gastrojejunostomy, and one patient with laparoscopic total gastrectomy. At final pathologic examinations, 20 patients were of stage IA and 3 were of stage IB according to the UICC TNM classification (6th ed.).Endoscopic blood tattooing provides a simple and useful means of localizing lesions during TLDG for EGC. Although the superiority of this technique over other localization methods needs to be evaluated further, the authors recommend endoscopic blood tattooing as an alternative to other intraoperative localization methods for laparoscopic surgery for EGC.

Purpose: In an effort to examine the clinicopathological characteristics of GC and the status of its surgical treatment, the Korean Gastric Cancer Association (KGCA) conducted a nationwide survey targeting surgically-treated gastric cancer patients in 2009. Materials and Methods: A standardized electrical case report was sent to every member institution of the KGCA via E-mail with detailed instructions regarding the survey data. Completed data forms were retrieved from each institution and analyzed by the KGCA information committee. Results: Data on 14,658 patients was collected from 59 institutions. The mean patient age was 59.2±11.9 years with a male to female ratio of 2.05 : 1. Lower third cancer (56.0%) was the most common among all gastric cancers. The histological type revealed poorly differentiated adenocarcinoma (34.1%) to be the most common, and the Lauren classification revealed the intestinal type (50.0%) to be the most prevalent. Curative surgery was performed in 92.4% of patients with laparoscopic surgery in 25.8% of patients. A Billroth I reconstruction was performed most frequently after a distal gastrectomy (63.4% of distal gastrectomy). T1 cancers accounted for 57.6% of all cases, and 62.6% of patients showed no lymph node metastasis. Compared to previous reports, it was found that patients are becoming older, laparoscopic surgery is being performed increasingly, and the proportion of T1 cancer is increasing with time. Conclusions: This survey presented the clinicopathological characteristics and current status of the surgical treatment of gastric cancer in Korea. This survey is expected aid research studies as well as planning and evaluation programs targeting cancer control.

Laparoscopic total gastrectomy (LTG) has not become as popular as laparoscopic distal gastrectomy (LDG) because of the more difficult reconstruction technique. Despite various modifications of reconstruction methods after LTG, an optimal procedure has yet to be established. The authors report the newly developed reconstruction technique after LTG: intracorporeal circular stapling esophagojejunostomy using the transorally inserted anvil (OrVil; Covidien, Mansfield, MA, USA).After full mobilization of the abdominal esophagus, the esophagus is transected with an endoscopic linear stapler. The anvil is then transorally inserted into the esophagus by using the OrVil system. After jejunojejunostomy is performed through a 4-cm midline minilaparotomy, preparing a 50-cm Roux-en-Y jejunal limb, a circular stapler is inserted into the jejunum and introduced into the abdominal cavity. Pneumoperitoneum is established by sealing off the laparotomy wound retractor with a surgical glove attached to the circular stapler. Double-stapling esophagojejunostomy with a circular stapler is performed intracorporeally, and the jejunal stump is closed with an endoscopic linear stapler.Of the 16 patients who underwent this operation, there was no intraoperative complication or conversion to open surgery, and no patient required an extension of the initial incision for anastomosis. Mean operation time and blood loss were 194 min and 272 ml, respectively. One patient developed an intra-abdominal abscess postoperatively. Postoperative fluorography revealed no anastomosis leakage or stenosis in any of the patients. Patients resumed an oral liquid diet on postoperative day 3-5, and the mean postoperative hospital stay was 11 days.We have successfully performed LTG with Roux-en-Y reconstruction using our technique in 16 patients without any anastomosis complications. We believe that our procedure is a secure and reliable reconstruction method after LTG, which is especially useful in obese patients, in whom conventional extracorporeal anastomosis often is difficult.

Reduced port laparoscopic surgery may lead to less pain and better cosmetic outcome than conventional surgery. Also, it requires fewer assistants and abdominal ports. Recently, some experts have reported operative techniques and outcomes of reduced port laparoscopic gastrectomy. In this study, we sought to introduce our techniques of duet laparoscopic distal gastrectomy (duet-LDG) using three abdominal ports and surgical outcomes of early experience of this procedure. Between 2010 and 2014, 431 patients undergoing LDG for gastric carcinoma were retrospectively reviewed. Among them, 49 patients underwent duet-LDG. During duet-LDG, an operator performed all the procedures using two abdominal ports with an additional umbilical laparoscopy port. Short-term surgical outcomes of duet-LDG were compared with conventional LDG groups. The mean age of the duet-LDG group was 61.1 years with 38 males and 11 females. Forty patients underwent Billroth II, and 9 patients underwent Roux-en-Y reconstruction. The mean operating time was 147 min, and the mean intraoperative blood loss was 49 ml. Duet-LDG was successfully completed without intraoperative complications or open conversion in all patients. After an operation, six patients (12.2 %) developed postoperative complications, and no mortality occurred. The mean hospital stay was 8.6 days. When compared with the conventional LDG groups, patients who underwent duet-LDG showed no significant differences in short-term surgical outcomes including morbidity, mortality, and the duration of hospital stay. Duet-LDG is a viable alternative to conventional LDG for treating early gastric carcinoma providing comparable surgical outcomes. Less operative pain and scar, reduced medical cost, and requiring fewer assistants may benefit patients as well as surgeons. Finally, the efficacy of duet-LDG needs to be evaluated in diverse clinical aspects.

Background: Despite the well-described benefits of laparoscopic surgery such as lower operative blood loss and enhanced postoperative recovery in gastric cancer surgery, the application of laparoscopic surgery in patients with locally advanced gastric cancer (AGC) remains elusive owing to a lack of clinical evidence. Recently, the Korean Laparoscopic Surgical Society Group launched a new multicenter randomized clinical trial (RCT) to compare laparoscopic and open D2 lymphadenectomy for patients with locally AGC. Here, we introduce the protocol of this clinical trial. Methods/design: This trial is an investigator-initiated, randomized, controlled, parallel group, non-inferiority trial. Gastric cancer patients diagnosed with primary tumors that have invaded into the muscle propria and not into an adjacent organ (cT2–cT4a) in preoperative studies are recruited. Another criterion for recruitment is no lymph node metastasis or limited perigastric lymph node (including lymph nodes around the left gastric artery) metastasis. A total 1,050 patients in both groups are required to statistically show non-inferiority of the laparoscopic approach with respect to the primary end-point, relapse-free survival of 3 years. Secondary outcomes include postoperative morbidity and mortality, postoperative recovery, quality of life, and overall survival. Surgeons who are validated through peer-review of their surgery videos can participate in this clinical trial. Discussion: This clinical trial was designed to maintain the principles of a surgical clinical trial with internal validity for participating surgeons. Through the KLASS-02 RCT, we hope to show the efficacy of laparoscopic D2 lymphadenectomy in AGC patients compared with the open procedure. Trial registration: ClinicalTrial.gov, NCT01456598.

Technical proficiency at laparoscopic D2 lymph node dissection (LND) is essential for extending the use of laparoscopic surgery beyond the treatment of early gastric cancer (EGC). The aim of this study was to evaluate the technical and oncological feasibility of laparoscopic distal gastrectomy (LDG) with D2 LND for distal gastric cancer.Of 922 patients who underwent open or LDG with D2 LND for gastric carcinoma, 133 treated by LDG and 133 treated by open distal gastrectomy (ODG) were selected using the propensity score matching method. The short-term surgical outcomes and long-term survivals of these matched groups were compared.The two study groups were well matched with respect to age, sex, body mass index, comorbidity, ASA score, abdominal operation history, and tumor stage. The LDG group had a significantly longer mean operating time (227 vs. 161 min, p0.001) but showed significantly less intraoperative blood loss (149 vs. 189 ml, p = 0.007). Total numbers of collected lymph nodes were similar in the two groups. Postoperatively, no significant intergroup differences were found for hospital stay, morbidity, or mortality. Furthermore, overall survivals were similar in the two groups (p = 0.621). Multivariate analysis showed that male gender, age ≥70 years, and intraoperative blood loss of ≥200 ml were independent risk factors of postoperative morbidity.Laparoscopic D2 LND for distal gastric cancer is technically safe and feasible compared with ODG. A prospective randomized trial is warranted to evaluate long-term oncological outcomes in advanced gastric carcinoma.

To evaluate the technical feasibility and safety of laparoscopic total gastrectomy (LTG) for gastric carcinoma, this study compared short-term surgical outcomes between LTG and open total gastrectomy (OTG) using the propensity score matching method.After generating propensity scores given the covariates of age, sex, body mass index, comorbidity, American Society of Anesthesiologists (ASA) score, operators, and tumor stage, 122 patients with LTG were matched to 122 OTG patients using the nearest available score matching. Operative outcomes and hospital courses were compared in the matched groups and in the subgroups by the extent of lymph node dissection (LND).The 2 study groups were well balanced with respect to the baseline characteristics of the propensity score derivation model. In the analysis of overall patients, the LTG group showed significantly longer operating time (289 vs 203 min, p0.001), but postoperative outcomes, including hospital stay, morbidity, and mortality, were similar in the 2 groups. In the subgroup with D1 + ß LND (perigastric nodes + Nos. 7, 8a, 9, 11p), the LTG group showed no significant differences in hospital stay, morbidity, and mortality from the OTG group. However, in the subgroup with D2 LND (perigastric nodes + Nos. 7, 8a, 9, 10, 11p, 11d, 12a), the LTG group showed significantly increased morbidity (52.6% vs 21.0%, p = 0.007) and tendency toward increased length of hospital stay and mortality as compared with the OTG group.Laparoscopic total gastrectomy is a safe and feasible technique for treatment of upper gastric carcinoma. However, LTG with D2 LND for upper gastric cancer may increase the operative risk and requires considerable experience in laparoscopic surgery.

4062Background: Although lots of benefits of laparoscopic gastric cancer surgery have been reported, strong evidences of laparoscopic surgery are still limited, especially in locally advanced gastr...

Laparoscopy-assisted distal gastrectomy (LADG) was first introduced in 1994 by Dr. Kitano, and was rapidly adopted in Japan, Korea, and China, where gastric cancer remains an endemic disease. However, in other parts of the world, laparoscopic gastrectomy has been relatively unpopular as compared to laparoscopic surgery for other organs, such as colorectal cancer surgery, because lymph node dissection and reconstruction method are more complicated than other organ cancer surgery.

Along with the marked increase in early gastric cancer (EGC) in the Eastern countries, there has been an effort to adopt the sentinel node concept in EGC to preserve gastric function and reduce the occurrence of postoperative complications. Based on promising results from a previous quality control study, this prospective multicenter randomized controlled phase III clinical trial aims to elucidate the oncologic safety of laparoscopic stomach-preserving surgery with sentinel basin dissection (SBD) compared to a standard laparoscopic gastrectomy. This trial is an investigator-initiated, open-label, multicenter randomized controlled phase III trial with a non-inferiority design. Patients diagnosed with a single lesion of clinical stage T1N0M0 gastric adenocarcinoma, with a diameter of 3 cm or less are eligible for the present study. A total of 580 patients (290 per group) will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival (DFS) and the secondary endpoints include postoperative morbidity and mortality, quality of life, 5-year DFS, and overall survival. Qualified investigators who completed the prior quality control study are exclusively allowed to participate in this phase III clinical trial. The proposed trial is expected to verify whether laparoscopic stomach-preserving surgery with SBD achieves similar oncologic outcomes and improved quality of life compared to a standard gastrectomy in EGC patients. This study was registered at the NIH ClinicalTrial.gov database ( NCT01804998 ) on March 4th, 2013.