Totally laparoscopic versus laparoscopy-assisted distal gastrectomy: the KLASS-07, a randomized controlled trial.

BACKGROUNDS: Strong evidence is lacking as no confirmatory randomized controlled trials (RCTs) have compared the efficacy of totally laparoscopic distal gastrectomy (TLDG) with laparoscopy-assisted distal gastrectomy (LADG). We performed an RCT to confirm if TLDG is different from LADG. METHODS: The KLASS-07 trial is a multicentre, open-label, parallel-group, phase III, RCT of 442 patients with clinical stage I gastric cancer. Patients were enrolled from 21 cancer care centers in South Korea between January 2018 and September 2020 and randomized to undergo TLDG or LADG using blocked randomization with a 1:1 allocation ratio, stratified by the participating investigators. Patients were treated through R0 resections by TLDG or LADG as the full analysis set of the KLASS-07 trial. The primary endpoint was morbidity within postoperative day 30, and the secondary endpoint was QoL for 1 year. This trial is registered at ClinicalTrials.gov (NCT NCT03393182). RESULTS: 442 patients were randomized (222 to TLDG, 220 to LADG), and 422 patients were included in the pure analysis (213 and 209, respectively). The overall complication rate did not differ between the two groups (TLDG vs. LADG: 12.2% vs. 17.2%). However, TLDG provided less postoperative ileus and pulmonary complications than LADG (0.9% vs. 5.7%, P= 0.006; and 0.5% vs. 4.3%, P= 0.035, respectively). The QoL was better after TLDG than after LADG regarding emotional functioning at 6 months, pain at 3 months, anxiety at 3 and 6 months, and body image at 3 and 6 months (all P< 0.05). However, these QoL differences were resolved at 1 year. CONCLUSIONS: The KLASS-07 trial confirmed that TLDG is not different from LADG in terms of postoperative complication but has advantages to reduce ileus and pulmonary complications. TLDG can be a good option to offer better QoL in terms of pain, body image, emotion, and anxiety at 3-6 months.

Comparative Analysis of Various Weight Loss Success Criteria Models After Bariatric Metabolic Surgery in Korean Morbid Obese Patients.

Purpose: To identify weight loss prediction models by validating previous models using weight loss success criteria. Materials and Methods: Patients with morbid obesity from 4 hospitals were retrospectively analyzed between Jan 2019 and 2022. Preoperative demographics, postoperative data, and 1-year follow-up weight loss outcomes were compared between 2 groups who underwent laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB). Additionally, the predictive factors for the success of excess weight loss (EWL) (>50%) and total weight loss (TWL) (>25%) were analyzed. Results: Of the 162 patients, 137 were enrolled during the study period, 75 underwent LSG, and 62 underwent LRYGB. The >50% EWL and >25% TWL 1 year after surgery were 61.3% and 43.1%, respectively. Diabetes mellitus medication use was reduced in 94.8% of patients with type 2 diabetes mellitus. Male sex and body mass index (BMI) were independent risk factors for successful weight loss (SWL) or >50% EWL (odds ratio [OR] for BMI 0.830, 95% confidence interval [CI] 0.764-0.902), whereas achieving >25% TWL was not affected by sex or BMI (OR for BMI 1.010, 95% CI 0.957-1.065). External validation of the prediction models showed an acceptable range of accuracy (adjusted R2 66.5-71.3%). Conclusion: LSG and LRYGB are feasible and effective bariatric procedures for SWL in Korean patients with morbid obesity. The TWL model was a more appropriate criterion than EWL, and weight loss prediction models may help assess the 1-year outcomes of bariatric surgery.

Long-Term Survival Outcomes of Elderly Patients Treated With S-1 or Capecitabine Plus Oxaliplatin for Stage II or III Gastric Cancer: A Multicenter Cohort Study.

Purpose: Tegafur/gimeracil/oteracil (S-1) and capecitabine plus oxaliplatin (CAPOX) are standard adjuvant chemotherapies (ACs) administered after gastrectomy to patients with stage II or III gastric cancer. However, the efficacy of AC in elderly patients remains unclear. The objective of this retrospective multicenter cohort study was to compare the efficacies of S-1 and CAPOX AC in patients aged ≥70 years. Materials and Methods: Nine hundred eighty-three patients who were treated with AC using S-1 (768 patients) or CAPOX (215 patients) were enrolled in this study. Each patient underwent AC after curative gastrectomy for stage II or III gastric cancer at one of 27 hospitals in the Republic of Korea between January 2012 and December 2013. Relapse-free survival (RFS) and overall survival (OS) were analyzed according to AC regimen and age group. Results: Of the 983 patients, 254 (25.8%) were elderly. This group had a similar RFS (P=0.099) but significantly poorer OS (p=0.003) compared with the non-elderly group. Subgroup analysis of the non-elderly group revealed no AC-associated differences in survival. Subgroup analysis of the elderly group revealed significantly better survival in the S-1 group than in the CAPOX group (RFS, P<0.001; OS, P<0.001). Multivariate analysis revealed that the CAPOX regimen was an independent poor prognostic factor for RFS (hazard ratio [HR], 1.891; 95% confidence interval [CI], 1.072-3.333; P=0.028) and OS (HR, 2.970; 95% CI, 1.550-5.692; P=0.001). Conclusions: This multicenter observational cohort study found significant differences in RFS and OS between S-1 and CAPOX AC among patients with gastric cancer aged ≥70 years.

Impact of the Deep Neuromuscular Block on Oncologic Quality of Laparoscopic Surgery in Obese Gastric Cancer Patients: A Randomized Clinical Trial.

BACKGROUND: Obesity can hinder laparoscopic procedures and impede oncological safety during laparoscopic cancer surgery. Deep neuromuscular block (NMB) reportedly improves laparoscopic surgical conditions, but its oncological benefits are unclear. We aimed to evaluate whether deep NMB improves the oncologic quality of laparoscopic cancer surgery in obese patients. STUDY DESIGN: We conducted a double-blinded, parallel-group, randomized, phase 3 trial at 9 institutions in Korea. Clinical stage I and II gastric cancer patients with a BMI at or above 25 kg m -2 were eligible and randomized 1:1 ratio to the deep or moderate NMB groups, with continuous infusion of rocuronium (0.5-1.0 and 0.1-0.5 mg kg -1 h -1, respectively). The primary endpoint was the number of retrieved lymph nodes (LNs). The secondary endpoints included the surgeon's surgical rating score (SRS) and interrupted events. RESULTS: Between August 2017 and July 2020, 196 patients were enrolled. Fifteen patients were excluded, and 181 patients were finally included in the study. There was no significant difference in the number of retrieved LNs between the deep (N = 88) and moderate NMB groups (N = 93; 44.6 ± 17.5 vs 41.5 ± 16.9, p = 0.239). However, deep NMB enabled retrieving more LNs in patients with a BMI at or above 28 kg/m2 than moderate NMB (49.2 ± 18.6 vs 39.2 ± 13.3, p = 0.026). Interrupted events during surgery were lower in the deep NMB group than in the moderate NMB group (21.6% vs 36.6%; p = 0.034). The SRS was not influenced by NMB depth. CONCLUSION: Deep NMB provides potential oncologic benefits by retrieving more LNs in patients with BMI at or above 28 kg/m2 during laparoscopic gastrectomy.

Appropriate Number of Adjuvant Chemotherapy Cycles for Patients with Stage 2 or 3 Gastric Cancer After Curative Gastrectomy: A Multicenter Cohort Study.

BACKGROUND: Few studies have presented evidence pertaining to the adequate minimum number of adjuvant chemotherapy (AC) cycles required to achieve an oncologic benefit for gastric cancer. METHODS: From January 2012 to December 2013, data from patients who underwent curative radical gastrectomy and consequently received AC for pathologic stage 2 or 3 gastric cancer at 27 institutions in South Korea were analyzed. RESULTS: The study enrolled 925 patients, 661 patients (71.5%) who completed 8 cycles of AC and 264 patients (28.5%) who did not. Compared with the mean disease-free survival (DFS) of the patients who completed 8 AC cycles (69.3 months), the mean DFS of patients who completed 6 AC cycles (72.4 months; p = 0.531) and those who completed 7 AC cycles (63.7 months; p = 0.184) did not differ significantly. However, the mean DFS of the patients who completed 5 AC cycles (48.2 months; p = 0.016) and those who completed 1-4 AC cycles (62.9 months; p = 0.036) was significantly lower than the DFS of those who completed 8 AC cycles. In the multivariate Cox proportional hazards analysis, the mean DFS was significantly affected by advanced stage, large tumor size, positive vascular invasion, and number of completed AC cycles (1-5 cycles: hazard ratio 1.45; 95% confidence interval 1.01-2.08; p = 0.041). CONCLUSION: The current multicenter observational cohort study showed that the mean DFS for 6 or 7 AC cycles was similar to that for 8 AC cycles as an adjuvant treatment for gastric cancer.

Short-term comparative study of three-dimensional and two-dimensional laparoscopic surgery for total extraperitoneal primary inguinal hernia repair.

Purpose: The aim of this study was to compare the short-term outcomes of two-dimensional (2D) and three-dimensional (3D) laparoscopic surgery for total extraperitoneal (TEP) primary inguinal hernia repair. Methods: This was a single-center, retrospective, observational database study of 38 patients who underwent laparoscopic TEP inguinal hernia repair from March 1, 2019 to August 30, 2019 at Kyung Hee University Hospital at Gangdong in Seoul, Korea. Results: There was no significant difference in sex ratio, age, or body mass index between the two groups. The 2D group had two patients with direct hernia and 18 patients with indirect hernia. The 3D group had five patients with direct hernia, 11 patients with indirect hernia, and two patients with femoral hernia. The mean operation time was 38.2 minutes in the 2D group compared with 37.2 minutes in the 3D group. There was no severe intraoperative bleeding in either group. During the operation, peritoneal tearing occurred in 12 out of 20 patients in the 2D group compared with five out of 18 patients in the 3D group (p = 0.02). The average length of hospital stay was 1.3 days in both groups. The numeric rating scale score was 3.3 and 3 in the 2D group and the 3D group, respectively. In the 2D group, two patients revisited the outpatient clinic because of the postoperative occurrence of seroma and varicocele. Conclusion: A 3D laparoscopic surgery is feasible and safe for inguinal hernia repair and showed less peritoneal tearing compared with 2D laparoscopic surgery for primary inguinal hernia repair.

Is the Sleeve Gastrectomy Sufficient or Does it Require Additional Surgical Procedures?

Laparoscopic sleeve gastrectomy is a relatively simple procedure and has become the most well-known bariatric surgical procedure in Korea and Western countries. However, this procedure has several disadvantages in terms of long-term weight loss and metabolic disease control. Laparoscopic sleeve gastrectomy and additional bypass (sleeve plus) procedures were recently introduced into bariatric surgery in order to combine the physiologic advantages of pyloric-saving reconstruction and the bypass effect. A sleeve gastrectomy was performed first, followed by a bypass procedure. This review describes sleeve plus procedures reported in the literature and compares their outcomes with the most frequently performed techniques.

Clinical Significance of Paraspinal Muscle Parameters as a prognostic factor for survival in Gastric Cancer Patients who underwent Curative Surgical Resection.

Background: The quantitative and qualitative skeletal muscle parameters have been proposed to predict the outcome of patients with gastric cancer. However, the evidence for their association with long-term survival is still conflicting. This study aimed to investigate the effect of paraspinal muscle parameters on overall survival (OS) and disease-free survival (DFS) in patients with gastric cancer who underwent curative resection. Methods: Patients with stages I or II gastric cancer who underwent curative resection between October 2006 and June 2016 were identified from electrical medical records. Paraspinal muscle area and attenuation were measured at the level of the third lumbar vertebra using computerized tomography images. For the analysis of OS and DFS, proportional hazards model was used, incorporating demographic, pathologic, laboratory, and radiologic variables. Results: This study enrolled 296 patients (192 men and 104 women). In the multivariate proportional hazards model, total gastrectomy (hazard ratio [HR], 2.65; 95% Confidence interval [CI], 1.36-5.19; p = 0.0044), neutrophil-lymphocyte ratio (NLR) (HR, 1.27; 95% CI, 1.06-1.51; p = 0.0081), serum albumin level (HR, 0.16; 95% CI, 0.07-0.39; p < 0.0001), paraspinal muscle area adjusted for body surface area (PMABSA) (HR, 3.06; 95% CI, 1.65-5.67; p = 0.0004), and mean attenuation in paraspinal muscle (PMMA) (HR, 3.38; 95% CI, 1.75-6.53; p = 0.0003) were prognostic factors for OS. Similarly, total gastrectomy (HR, 2.11; 95% CI, 1.10-4.06; p = 0.0243), NLR (HR, 1.25; 95% CI, 1.06-1.48; p = 0.0071), serum albumin level (HR, 0.22; 95% CI, 0.10-0.51; p = 0.0035), PMABSA (HR, 2.42; 95% CI, 1.34-4.37; p = 0.0035), and PMMA (HR, 3.19; 95% CI, 1.71-5.93; p = 0.0003) were prognostic factors for DFS. Conclusions: The pretreatment paraspinal muscle parameters such as PMABSA and PMMA along with total gastrectomy, NLR, and serum albumin level could predict OS and DFS in patients with stages I or II gastric cancer who underwent curative surgical resection. Because PMABSA and PMMA are newly characterized parameters in gastric cancer, the relationship with the survival of these parameters requires further validation in further studies before they are subjected to clinical applications.

Long-term Efficacy of S-1 Monotherapy or Capecitabine Plus Oxaliplatin as Adjuvant Chemotherapy for Patients with Stage II or III Gastric Cancer after Curative Gastrectomy: a Propensity Score-Matched Multicenter Cohort Study.

PURPOSE: To compare long-term disease-free survival (DFS) between patients receiving tegafur/gimeracil/oteracil (S-1) or capecitabine plus oxaliplatin (CAPOX) adjuvant chemotherapy (AC) for gastric cancer (GC). MATERIALS AND METHODS: This retrospective multicenter observational study enrolled 983 patients who underwent curative gastrectomy with consecutive AC with S-1 or CAPOX for stage II or III GC at 27 hospitals in Korea between February 2012 and December 2013. We conducted propensity score matching to reduce selection bias. Long-term oncologic outcomes, including DFS rate over 5 years (over-5yr DFS), were analyzed postoperatively. RESULTS: The median and longest follow-up period were 59.0 and 87.6 months, respectively. DFS rate did not differ between patients who received S-1 and CAPOX for pathologic stage II (P=0.677) and stage III (P=0.899) GC. Moreover, hazard ratio (HR) for recurrence did not differ significantly between S-1 and CAPOX (reference) in stage II (HR, 1.846; 95% confidence interval [CI], 0.693-4.919; P=0.220) and stage III (HR, 0.942; 95% CI, 0.664-1.337; P=0.738) GC. After adjustment for significance in multivariate analysis, pT (4 vs. 1) (HR, 11.667; 95% CI, 1.595-85.351; P=0.016), pN stage (0 vs. 3) (HR, 2.788; 95% CI, 1.502-5.174; P=0.001), and completion of planned chemotherapy (HR, 2.213; 95% CI, 1.618-3.028; P<0.001) were determined as independent prognostic factors for DFS. CONCLUSIONS: S-1 and CAPOX AC regimens did not show significant difference in over-5yr DFS after curative gastrectomy in patients with stage II or III GC. The pT, pN stage, and completion of planned chemotherapy were prognostic factors for GC recurrence.

Nutritional Intervention for a Patient with Laparoscopic Sleeve Gastrectomy for Morbid Obesity: a Case Report.

Nutritional intervention for individual patients has a wide range of postoperative food adaptability, so an individual evaluation is required. The medical institution intends to examine the contents of nutritional arbitration conducted on patients who underwent gastric surgery, examine the results, identify the nutritional problems that can be seen through the course of the patient's meal process, and share the clinical experience. In this case study, a 46-year-old female patient was diagnosed with morbid obesity, impaired fasting glucose and hypertension. She was 153 cm tall and weighed 88 kg, with a body mass index 37.6 kg/m2 at initial evaluation. The patient maintained normal biochemical data before and after surgery and shows postoperative weight loss, body fat reduction, and abdominal fat reduction. In this case, blood sugar and blood lipid levels improved after weight loss. The repeated nutritional intervention for a sleeve gastrectomy patient, which is performed by clinical dietitians, is as follows. A balanced diet, supplemented with vitamins and minerals, is very important for preventing nutritional complications after obesity surgery. In conclusion, for stomach surgery patients, a multidisciplinary approach and continuous nutritional management, motivation for weight loss, postoperative dietary adaptation, and individual access to patients are most important.

Multicenter Retrospective Analysis of Intraperitoneal Paclitaxel and Systemic Chemotherapy for Advanced Gastric Cancer with Peritoneal Metastasis.

PURPOSE: The objective of the present retrospective analysis was to describe the experience of intraperitoneal (IP) paclitaxel and systemic chemotherapy in patients with peritoneal metastasis (PM) of advanced gastric cancer (AGC) in a multicenter setting in Korea. MATERIALS AND METHODS: The medical records of patients with AGC, who were diagnosed with PM between January 2015 and December 2018, were reviewed. IP catheter was placed in the pouch of Douglas and was used for the administration of IP paclitaxel chemotherapy. RESULTS: We reviewed the clinical outcomes of IP paclitaxel and systemic chemotherapy administration in 82 patients at six institutions in Korea. Mean number of IP chemotherapy cycles was 6.6. The mean peritoneal cancer index (PCI) was 21.9. Postoperative complications related to IP catheter and port were observed in 15 patients. The overall median survival was 20.0 months. A significant difference was observed in the survival rate according to the ascites grade (grade I and II, 24.1 months; grade III and IV, 15.3 months; P=0.014) and PCI grade (grade I, 25.6 months; grade II and III, 16.3 months; P=0.023). CONCLUSIONS: The feasibility of IP paclitaxel and systemic chemotherapy administration was demonstrated in this experience-based retrospective analysis suggesting that the procedure is beneficial in patients with PM of AGC.

Short-Term Outcomes of Laparoscopic Sleeve Gastrectomy with Duodenojejunal Bypass for Morbid Obesity.

Purpose: This study aimed to evaluate the safety and feasibility of laparoscopic sleeve gastrectomy with duodenojejunal bypass (SDJB) surgery in Korean patients. Materials and Methods: This was a retrospective study analyzing SDJB surgery with a 200-cm biliopancreatic limb; the surgery was performed between January 2019 and August 2020 in 56 Koreans with morbid obesity. All demographic, clinical, operative, and follow-up data were documented and analyzed for weight loss and diabetes remission efficacy. Safety and feasibility were analyzed in terms of perioperative and postoperative complications. A decrease in the HbA1c value and discontinuation or reduction of anti-diabetics were considered as indicators of improvement in diabetes. Results: he median operation time was 180.0 min (105-210 min), and the median postoperative hospital stay was 5.0 days (3-35 days). Postoperative complications occurred in two patients who were managed by conversion to Roux-en-Y gastric bypass surgery. Meaningful weight loss was 3.5%, 27.7%, and 54.9% at the 1-month, 3-month, and 6-month follow-ups, respectively. Of the 56 patients, 46 had type 2 diabetes. Among those patients, at the 1-month follow-up, 4/31 patients (12%), at the 3-month follow-up, 22/41 patients (53.6%), and at the 6-month follow-up, 31/42 patients (73.8%) were found to show improvement. Of the patients who received anti-diabetics or insulin therapy, only three (9%) patients continued to receive reduced treatment of diabetes, and the other thirty (91%) discontinued the anti-diabetics. Conclusion: SDJB surgery with a 200-cm biliopancreatic limb was a safe and effective procedure to treat morbid obesity and diabetes.

The expression of C-MYC in gastric adenocarcinoma is associated with PD-L1 and FOXP3 expression: C-MYC overexpression is a good prognostic factor.

BACKGROUND: C-MYC appears to initiate and maintain tumorigenesis through modulation of immune regulatory molecules such as PD-L1. The aim of our research was to evaluate the clinical implication of C-MYC expression in gastric adenocarcinoma in relation to the expression of the immune regulatory molecules PD-L1 and FOXP3. METHODS: Tissue samples were acquired from 182 cases of gastric adenocarcinoma that were surgically resected at Kyung Hee University Hospital at Gangdong from 2006 to 2012. Immunohistochemical staining for C-MYC, PD-L1, CD8 and FOXP3 was done. RESULTS: C-MYC overexpression showed a significant correlation with smaller tumor size, lower T category, lower N category, lower recurrence rate, and less lymphatic invasion. And C-MYC overexpression was negatively correlated with PD-L1 expression. The tumoral FOXP3 was positively correlated with C-MYC overexpression and Tregs count. PD-L1 expression was positively correlated with Tregs, CD8 + T cells, and tumor infiltrating lymphocytes (TIL). Tregs count was positively correlated with CD8 + T cells and TIL. CD8 + T cells was positively correlated with TIL. CONCLUSION: We discovered that the immune regulatory effect of C-MYC and PD-L1, and the tumor suppressor function of tumoral FOXP3 had a significant influence on the tumor microenvironment (Tregs, CD8 + T cells, and tumor infiltrating lymphocytes) in a complex manner. The C-MYC overexpression is a good prognostic factor in gastric adenocarcinoma.

The AMPK-Parkin axis negatively regulates necroptosis and tumorigenesis by inhibiting the necrosome.

The receptor-interacting serine/threonine-protein kinases RIPK1 and RIPK3 play important roles in necroptosis that are closely linked to the inflammatory response. Although the activation of necroptosis is well characterized, the mechanism that tunes down necroptosis is largely unknown. Here we find that Parkin (also known as PARK2), an E3 ubiquitin ligase implicated in Parkinson's disease and as a tumour suppressor, regulates necroptosis and inflammation by regulating necrosome formation. Parkin prevents the formation of the RIPK1-RIPK3 complex by promoting polyubiquitination of RIPK3. Parkin is phosphorylated and activated by the cellular energy sensor AMP-activated protein kinase (AMPK). Parkin deficiency potentiates the RIPK1-RIPK3 interaction, RIPK3 phosphorylation and necroptosis. Parkin deficiency enhances inflammation and inflammation-associated tumorigenesis. These findings demonstrate that the AMPK-Parkin axis negatively regulates necroptosis by inhibiting RIPK1-RIPK3 complex formation; this regulation may serve as an important mechanism to fine-tune necroptosis and inflammation.

Meta-analysis and systematic review on laparoscopic-assisted distal gastrectomy (LADG) and totally laparoscopic distal gastrectomy (TLDG) for gastric cancer: Preliminary study for a multicenter prospective KLASS07 trial.

BACKGROUND: The curative surgical treatment of gastric cancer in the current laparoscopic surgical era relies on the surgeon's preference, technical difficulties, and concerns regarding outcome have led to the availability of totally laparoscopic distal gastrectomy (TLDG) and laparoscopic-assisted distal gastrectomy (LADG). A consensus on which of the two procedures is preferable is necessary. Therefore, the aim of this study was to evaluate the differences between LADG and TLDG in terms of surgical outcomes, postoperative recovery, pain, and complications. METHODS: PubMed, Google Scholar, Medline, Embase, and Cochrane databases were explored up to 2017 to evaluate TLDG and LADG. Parameters including surgical outcomes, postoperative recovery, and postoperative complications were subjected to meta-analysis to calculate the odds ratio and weighted mean difference with 95% confidence intervals (c.i.). RESULTS: Twenty-five studies (24 non-RCT and 1 RCT) with a total of 4562 gastric cancer patients were included in the meta-analysis. Under reconstruction-matched analysis, overall complications and anastomotic complications were similar for TLDG and LADG. Nevertheless, short-term outcomes such as blood loss, time to first soft diet, hospital stay, analgesic use, and CRP level were favourable for TLDG, while all other surgical outcomes showed no difference. CONCLUSIONS: TLDG and LADG did not show significant differences in surgical outcomes and postoperative complications, including anastomotic-related morbidity. Therefore, decisive factors in selecting surgical procedures, which previously consisted of surgical outcomes, have been superseded by extra-surgical values such as cosmesis, economics, and patient's quality of life. These factors will be explored in a future multicentre prospective study (KLASS07 trial).

Oncologic Outcomes after Laparoscopic and Open Distal Gastrectomy for Advanced Gastric Cancer: Propensity Score Matching Analysis.

PURPOSE: This study aimed to compare the oncologic and short-term outcomes of laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) for advanced gastric cancer (AGC). MATERIALS AND METHODS: From July 2006 to November 2016, 384 patients underwent distal gastrectomy for AGC. Data on short- and long-term outcomes were prospectively collected and reviewed. Propensity score matching was applied at a ratio of 1:1 to compare the LDG and ODG groups. RESULTS: The operative times were longer for the LDG group than for the ODG group. However, the time to resumption of diet and the length of hospital stay were shorter in the LDG group than in the ODG group (4.7 vs. 5.6 days, P=0.049 and 9.6 vs. 11.5 days, P=0.035, respectively). The extent of lymph node dissection in the LDG group was more limited than in the ODG group (P=0.002), although there was no difference in the number of retrieved lymph nodes between the 2 groups. The 3-year overall survival rates were 98% and 86.9% (P=0.018), and the 3-year recurrence-free survival rates were 86.3% and 75.3% (P=0.259), respectively, in the LDG and ODG groups. CONCLUSIONS: LDG is safe and feasible for AGC, with earlier recovery after surgery and long-term oncologic outcomes comparable to those of ODG.

A multi-center prospective randomized controlled trial (phase III) comparing the quality of life between laparoscopy-assisted distal gastrectomy and totally laparoscopic distal gastrectomy for gastric Cancer (study protocol).

BACKGROUND: KLASS (the Korean Laparoendoscopic Gastrointestinal Surgery Study) is a time-honored study group that has established laparoscopic surgery for gastrointestinal disease in Korea and has performed some important studies for the rationale of laparoscopic gastrointestinal surgery. A multi-center RCT (randomized controlled trial) to compare the quality of life (QOL) of patients undergoing totally laparoscopic distal gastrectomy (TLDG) and laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer, named as KLASS 07, has been currently prepared in Korea. METHODS: Patients diagnosed as gastric cancer, with clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 7th edition of the Americal Joint Committee on Cancer System, were randomized to receive either TLDG or LADG. For surgical quality control, the surgeons participating in this trial had to have performed at least 50 gastrectomies and at least 30 gastrectomies annually (regardless of open or laparoscopic surgery for gastric cancer). The patients who are allocated to TLDG group undergo intracorporeal anastomosis and those who are assigned to LADG undergo extracorporeal anastomosis for gastrointestinal reconstruction. DISCUSSION: Thirty-one surgeons from 26 institutions were engaged in this trial. The primary endpoint is 30-day morbidity, and secondary endpoint is QOL assessed by the questionnaire score. The KLASS 07 trial is the first multi-center RCT to investigate whether there are significant and quantifiable differences between the QOL of TLDG and LADG. The findings from this trial are expected to be the critical clues for designing the detailed procedures during laparoscopic surgery for gastric cancer. TRIAL REGISTRATION: The protocol of KLASS 07 (CKLASS 01) was registered in http://register.clinicaltrials.gov as NCT03393182 (Date of registration: January 2nd, 2018.).

Comparison of Postoperative Pain in Laparoscopy-Assisted Distal Gastrectomy and Totally Laparoscopic Distal Gastrectomy by Location of Mini-Laparotomy Site.

Purpose: We aimed to evaluate the clinical outcomes and determine the degree of postoperative pain associated with the location of mini-laparotomy sites in gastric cancer patients who underwent laparoscopic-assisted distal gastrectomy (LADG) or totally laparoscopic distal gastrectomy (TLDG). Methods: Between November 2011 and December 2016, 153 patients who underwent surgery for gastric cancer at Kyung Hee University Hospital at Gangdong were reviewed retrospectively. We divided the patients into LADG with epigastric incision, TLDG with umbilical incision (TLDG_U), and TLDG with Pfannenstiel incision (TLDG_P) groups according to the location of incision for anastomosis and specimen removal. There were 37 cases in the LADG group, 85 in the TLDG_U group, and 31 in the TLDG_P group. The clinical characteristics, numeric rating scale (NRS) scores, and postoperative analgesic usage for 7 days of the three groups were compared. Results: There was no statistically significant difference in clinical characteristics including age, sex, body mass index (BMI), TNM staging, and complications among the three groups. There was no significant difference in the amount of total analgesics received; however, the TLDG_P group received more analgesics (5.26±5.053, p=0.412) during the first 7 postoperative days. The TLDG_P group showed higher NRS scores on postoperative days 0, 2, 3, 4, and 5 (p=0.04, 0.001, 0.003, 0.006, and 0.002 respectively). Conclusion: Laparoscopic distal gastrectomy can be performed through various incision sites for increasing the safety of mini-laparotomy. However, a Pfannenstiel incision was shown to be more painful than other incisions.

Comparison of oncological benefits of deep neuromuscular block in obese patients with gastric cancer (DEBLOQS_GC study): A study protocol for a double-blind, randomized controlled trial.

PURPOSE: Many studies have demonstrated the advantage of maintaining intraoperative deep neuromuscular block (NMB) with sugammadex. This trial is designed to evaluate the impact of muscle relaxation during laparoscopic subtotal gastrectomy on the oncological benefits, particularly in obese patients with gastric cancer. MATERIALS AND METHODS: This is a double-blind, randomized controlled multicenter prospective trial. Patients with clinical stage I-II gastric cancer with a body mass index of 25 and over, who undergo laparoscopic subtotal gastrectomy will be eligible for trial inclusion. The patients will be randomized into a deep NMB group or a moderate NMB group with a 1:1 ratio. A total of 196 patients (98 per group) are required. The primary endpoint is the number of harvested lymph nodes, which is a critical index of the quality of surgery in gastric cancer treatment. The secondary endpoints are surgeon's surgical condition score, patient's sedation score, and surgical outcomes including peak inspiratory pressure, operation time, postoperative pain, and morbidity. DISCUSSION: This is the first study that compares deep NMB with moderate NMB during laparoscopic gastrectomy in obese patients with gastric cancer. We hope to show the oncologic benefits of deep NMB compared with moderate NMB during subtotal gastrectomy. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT03196791), date of registration: October 10, 2017.