Safety and Efficacy Assessment of Red Ginseng Oil (RXGIN) in Men with Lower Urinary Tract Symptoms in a Randomized, Double-Blind, Placebo-Controlled Trial.

PURPOSE: The purpose of this study was to evaluate the efficacy and safety of red ginseng oil (RXGIN) in men with lower urinary tract symptoms. MATERIALS AND METHODS: Men aged between 40 and 75 years with a total International Prostate Symptom Score (IPSS) of 8 to 19 points were recruited from April 2020 to December 2020. Subjects were randomly assigned to either the RXGIN group or the control group in a 1:1 ratio and received either RXGIN or placebo daily for 12 weeks. For the primary outcome, changes in IPSS scores at 6 and 12 weeks from baseline were analyzed. The secondary outcomes were changes in International Index of Erectile Function (IIEF), maximum urinary flow rate, and post-void residual volume at weeks 6 and 12 compared to baseline. Urine analysis and blood tests were additionally performed for safety assessment. RESULTS: A total of 88 subjects (RXGIN group, 46; control group, 42) completed the study. The total IPSS and IPSS subscores (residual urine sensation, frequency, intermittency, urgency, weak stream, straining, nocturia, and quality of life) were significantly improved in the RXGIN group compared to the control group at weeks 6 and 12. Total IIEF and sexual desire were significantly improved in the RXGIN group at week 6 and week 12, respectively, but there were no significant changes in the level of serum testosterone or dihydrotestosterone. The serum prostate-specific antigen showed significant decrease at weeks 12. No serious adverse events leading to discontinuation of the study drug were observed in the RXGIN group. CONCLUSIONS: Red ginseng oil (RXGIN) appears to be safe and effective in improving lower urinary tract symptoms in men and may also improve some aspects of sexual function.

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.

Can We Reboot the Role of Intraperitoneal Chemotherapy in the Treatment for Gastric Cancer with Peritoneal Carcinomatosis?: A Retrospective Cohort Study Regarding Minimally Invasive Surgery Conjoined with Intraperitoneal plus Systemic Chemotherapy.

Background: Peritoneal carcinomatosis (PC) is the most common form of metastasis in gastric cancer (GC) and is related with a poor prognosis. Several treatment modalities including systemic chemotherapy and intraperitoneal chemotherapy have been studied and adopted in treatment of GC patients with PC. Nevertheless, few studies have reported the comparison of the oncologic outcomes between minimally invasive surgery (MIS) with intraperitoneal (IP) chemotherapy and conventional chemotherapy for GC with PC. Methods: We retrospectively reviewed the clinical records of 74 patients who had been diagnosed as GC with PC via either intra-abdominal exploration or abdominopelvic computed tomography between January 2011 and April 2021. After performing propensity score-matching for this retrospective data, we compared the outcomes of 26 patients who underwent MIS followed by IP combined systemic chemotherapy (MIS-IP group) and 26 patients who underwent systemic chemotherapy only (SC-only group). Results: The 2-year progression free survival rate of the MIS-IP group was significantly higher than the SC-only groups (36.4% and 10.5%, respectively; p = 0.010). In multivariate analysis to detect relevant factors on PFS, IP chemotherapy (HR 0.213; p < 0.001), Eastern Cooperative Oncology Group performance status (HR 3.689; p = 0.002), and the amount of ascites (p = 0.011) were significant prognostic factors. Conclusions: This study demonstrated the therapeutic potential of MIS conjoined IP plus systemic chemotherapy for GC patients with PC. MIS conjoined by IP plus systemic chemotherapy can be adopted as a treatment option to reboot the role of IP chemotherapy in GC patients with PC.

Effects of red ginseng oil(KGC11o) on testosterone-propionate-induced benign prostatic hyperplasia.

Background: Benign prostatic hyperplasia (BPH) is a disease characterized by abnormal proliferation of the prostate, which occurs frequently in middle-aged men. In this study, we report the effect of red ginseng oil (KGC11o) on BPH. Methods: The BPH-induced Sprague-Dawley rats were divided into seven groups: control, BPH, KGC11o 25, 50, 100, 200, and finasteride groups. KGC11o and finasteride were administered for 8 weeks. The BPH biomarkers, DHT, 5AR1, and 5AR2, androgen receptor, prostate-specific antigen (PSA), Bax, Bcl-2, and TGF-ß were determined in the serum and prostate tissue. The cell viability after KGC11o treatment was determined using BPH-1 cells, and, androgen receptor, Bax, Bcl-2, and TGF-ß were confirmed by western blotting. Results: In the in vivo study, administration of KGC11o reduced prostate weight by 18%, suppressed DHT (up to 22%) and 5AR2 (up to 12%) levels from administration of 100 mg/kg KGC11o (P < 0.05). PSA was significantly downregulated dose-dependently from at the concentration of 50 mg/kg KGC11o (P < 0.05). BPH-1 cell viability significantly reduced through the treatment with KGC11o. In vitro and vivo, AR, Bcl-2 TGF-ß levels reduced significantly but Bax was increased (P < 0.05). Conclusion: These results suggest that KGC11o may inhibit the development of BPH by significantly reducing the levels of BPH biomarkers via 5ARI, anti-androgenic effect, and anti-proliferation effect, serving as a potential functional food for treating BPH.

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.

Survival impact of compliance in extra-perigastric lymphadenectomy for gastric cancer: 20 years of real-world data from a single institution.

BACKGROUND: Compliance in lymphadenectomy was first introduced as part of quality control in a Dutch clinical trial. Although a few studies have investigated compliance, no studies have evaluated the survival impact at individual lymph node stations. METHODS: In total, 2,932 patients who underwent radical gastrectomy between 1996 and 2014 at the Korea University Guro Hospital in Seoul, South Korea were retrospectively reviewed. We compared survival outcomes among the compliance, noncompliance, and metastatic groups. RESULTS: The highest compliance among extra-perigastric stations was recorded for #8a (86.6%), followed by #7 (76.6%) and #9 (68.3%). Stations #11 and #12 showed low compliance rates of 28.9% and 31.0%, respectively. Compliance at #7, #8a, and #9 was related to better 5-year relapse-free survival rates (74.5%, 72.8%, and 71.3%, respectively) than noncompliance (61.9% [hazard ratio, 1.72; 95% confidence interval, 1.40-2.11], 61.0% [hazard ratio, 1.6; 95% confidence interval 1.26-2.04], 65.3% [hazard ratio, 1.25; 95% confidence interval 1.04-1.51], respectively). At #11 and #12, there were no significant differences in relapse-free survival between compliance (69.1% and 70.2%, respectively) and noncompliance (67.4% [hazard ratio, 0.85; 95% confidence interval 0.53-1.36], 65.1% [hazard ratio, 1.13; 95% confidence interval 0.71-1.81], respectively). In multivariable analysis, stations #7 and #8 alone showed an increased hazard ratio of relapse-free survival in the noncompliance group relative to the compliance group. CONCLUSION: We showed a survival benefit of compliance during lymphadenectomy for gastric cancer. Although further prospective trials to validate our results are warranted, compliance could be adopted in real-world practice to achieve better survival among patients with gastric cancer.

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.

Intraperitoneal Paclitaxel Combined with S-1 Plus Oxaliplatin for Advanced Gastric Cancer with Peritoneal Metastasis: a Phase I Study.

PURPOSE: We designed a new regimen by combining intraperitoneal (IP) paclitaxel (PTX) with systemic S-1 plus oxaliplatin (SOX) for the treatment of advanced gastric cancer with peritoneal metastasis. This dose-escalation study aimed to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IP PTX administered weekly to patients. MATERIALS AND METHODS: Eight cycles of IP PTX plus SOX regimen were administered to the patients. S-1 was administered orally twice daily at a dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days of rest. Intravenous oxaliplatin was administered at a fixed dose of 100 mg/m2 on day 1, while IP PTX was administered on days 1 and 8. The initial dose of IP PTX was 40 mg/m2, and the dose escalation was set in units of 20 mg/m2 up to 80 mg/m2. Dose-limiting toxicities (DLTs) were defined as grade 3 non-hematologic toxicities, grade 4 leukopenia, grade 3 febrile neutropenia, and grade 3 thrombocytopenia. RESULTS: Nine patients were included in the study. No DLTs were observed in any of the enrolled patients. Therefore, the MTD was not reached, and the RD of IP PTX was determined to be 80 mg/m2. Four patients (44%) showed a decreased peritoneal cancer index score on second-look laparoscopic examination. CONCLUSIONS: The present study determined the dose for further clinical trials of IP PTX to be 80 mg/m2, when combined with a systemic SOX regimen.

Comparison of the Clinical Outcomes Between Isoperistaltic and Antiperistaltic Anastomoses After Laparoscopic Distal Gastrectomy for Patients With Gastric Cancer.

Background: No consensus exists regarding the superiority of either of the two types of gastrointestinal anastomosis, which are isoperistaltic and antiperistaltic. This study aimed to compare the clinical outcomes between isoperistaltic and antiperistaltic anastomoses after total laparoscopic distal gastrectomy (TLDG) in patients with gastric cancer. Methods: We retrospectively reviewed the medical records of patients with gastric cancer who underwent TLDG with Billroth II anastomosis between January 2014 and December 2018. The patients were divided into two groups according to the peristaltic direction of gastrointestinal anastomosis after TLDG. One group underwent isoperistaltic anastomosis (Iso group), and the other underwent antiperistaltic anastomosis (Anti group). Clinical outcomes were compared between the groups. Results: Of the 148 patients who underwent TLDG with Billroth II anastomosis, 124 were included in the Iso group and 24 were included in the Anti group. The Anti and Iso groups showed no significant difference with regard to the incidence of internal hernia (0.0 vs. 6.5%, respectively; p = 0.355). The incidence of bile reflux was more frequent in the Iso group than in the Anti group (p = 0.010), but food stasis was more common in the Anti group than in the Iso group (p = 0.006). Conclusion: In gastric cancer patients who underwent TLDG in which postoperative adhesion was minimized, antiperistaltic anastomosis may have created a physiologic barrier in gastrointestinal continuity. However, a large-scale study is necessary to validate the relationship between the digestive stream and the peristaltic direction.

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.

Combination of Sargassum fusiforme and Pueraria lobata Extracts Alleviates Postmenopausal Symptoms in Ovariectomized Rats.

Estrogen, produced mainly in the ovaries, plays a role in sexual development, metabolism, and bone formation. Thus, estrogen deficiency due to menopause can lead to overweight, dyslipidemia, and osteoporosis. In this study, we compared the effects of extracts of Sargassum fusiforme, Pueraria lobata, and their mixtures at various ratios on osteosarcoma SaOS-2 cells and investigated the effect of PS31 (P. lobata: S. fusiforme = 3:1, KGC02PS) on postmenopausal symptoms in ovariectomized rats. PS31 supplementation, as little as 100 mg/kg BW, effectively reduced ovariectomy-induced weight gain, and total triglyceride, total cholesterol, and low-density lipoprotein-cholesterol concentrations in serum. In addition, PS31 supplementation prevented bone density loss, inhibited bone resorption, and reduced the expression of catabolic factors in bone. However, PS31 supplementation did not affect uterus weight and expression of c-Jun and c-Fos, which suggests that the mechanism of action of PS31 is distinct from that of estrogen. Taken together, we demonstrated that PS31 supplementation alleviated postmenopausal symptoms, including overweight, dyslipidemia, and osteoporosis. Therefore, PS31 could be potentially used as food supplement to prevent postmenopausal symptoms.

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.

Multicenter results of long-limb bypass reconstruction after gastrectomy in patients with gastric cancer and type II diabetes.

BACKGROUND/OBJECTIVE: The number of gastric cancer and type II diabetes mellitus is increasing in Korea. Metabolic surgery could be extended to gastric cancer patients with type II diabetes, especially those who are expected to achieve long-term survival. This study aimed to investigate change of diabetic status in patients undergoing long-limb Roux-en-Y bypass reconstruction compared with conventional Billroth II after curative gastrectomy. In total, 130 patients from five university hospital centers underwent long-limb Roux-en Y reconstruction after radical distal gastrectomy. METHODS: In the long-limb group, the length of biliopancreatic limbs was more than 80 cm, and the length of the Roux limb was more than 80 cm. The control group comprised 96 patients who underwent conventional Billroth II reconstruction after distal gastrectomy. Follow-up data at three, six, nine, and 12 months were compared between the two groups. RESULTS: Fasting blood sugar (FBS) and hemoglobin (Hb) A1c levels decreased more significantly in the long-limb Roux-en-Y group (FBS: 28.8 mg/dL; HbA1c: 0.72%). However, decreases in body mass index, albumin, and hemoglobin did not differ significantly between the two groups. Diabetes control significantly improved in the long-limb group. In multivariate analysis, long-limb bypass reconstruction was the significant factor for glycemic outcomes. CONCLUSION: Roux-en-Y bypass with increased length of limbs after gastrectomy shows a favorable glycemic control for gastric cancer patients with type II diabetes without nutritional deficit and anemia. To obtain future perspectives, large-scale prospective studies with long-term outcomes are needed.

Laparoscopic total gastrectomy as a valid procedure to treat gastric cancer option both in early and advanced stage: A systematic review and meta-analysis.

Although laparoscopic total gastrectomy (LTG) compared to open total gastrectomy (OTG) has been widely used for advanced gastric cancer patients, its oncologic validity is yet to be proven. We performed systemic review and meta-analysis to compare LTG versus OTG for early and advanced stages of gastric cancer. Short- and long-term outcomes of both procedures were analyzed using original studies collected by searching Google Scholar, Medline, PubMed, Embase, and Cochrane library in accordance with the PRISMA guidelines. To analyze procedures more precisely, we categorized studies into advanced gastric cancer (AGC) and early gastric cancer (EGC) groups and matched lymph node (LN) dissection, and metastasis ratio. Nineteen studies with a total of 3943 patients were included. LTG required more operative time and had less dissected LNs, indicating a favorable quality of OTG. However, LTG was superior with less blood loss, a shorter postoperative hospital stay, and lower postoperative complication rates. The 5-year survival rate was similar in both groups in which extent of LN dissection and lymph node metastasis ratio were controlled. Although more LNs were removed in OTG, the discrepancy had an insignificant impact on the survival rate. To the best of our knowledge, this study is the first to employ quantitative synthesis in evaluation of long-term oncologic validity of LTG and OTG in AGC, with LN dissection and N stage controlled setting. Non-inferiority of LTG on oncologic outcome and superiority of LTG on perioperative outcome lead to a conclusion that LTG has potential as a valid treatment modality in AGC.

Effect of Biologic Material Reinforcement on Surgical Anastomosis After Gastrectomy-A Pilot Study.

Background: Acellular dermal matrix is a biologic material derived from the skin of human cadaveric donors. It has been used successfully in the past to reduce complications in breast surgery and hernia repair. This investigation was aimed at assessing the feasibility of using acellular dermal matrix to support the anastomosis after gastrectomy with the aim of reducing anastomotic site leakage complications. Methods: Patients were randomly assigned to standard anastomotic reconstruction (control arm) or anastomotic reconstruction with acellular dermal matrix reinforcement (intervention arm). Surgical outcomes related to anastomotic complications were collected. Because actual anastomotic leaks found on imaging studies are infrequent and thus require a very high number of patient recruitment to detect statistically significant difference between the two groups, in this pilot investigation other clinical and laboratory measures that have been shown to correlate to or predict anastomotic leaks were also collected. Each surgical outcome was compared. Results: A total of 94 patients (intervention arm: 50, control arm: 44), were included in the analysis. Two patients in the control arm (4.55%) and one patient in the intervention arm (2.00%) experienced anastomotic leakage (p = 0.598), a difference without statistical significance. However, average postoperative C-reactive protein (CRP) levels and NUn scores, both of which have been shown to reflect likelihood of progressing to anastomotic leakage, were significantly lower for the intervention arm. The control arm showed an average CRP level of 128.77 mg/dL (SD: 97.08) while the intervention arm showed 77.38 mg/dL (SD: 49.08, p = 0.049). Conclusions: Leakage rate reduction with acellular dermal matrix reinforcement of anastomotic site was not detected in this investigation. However, postoperative inflammation levels and numerical predictors of anastomotic leakage development were significantly lower with acellular dermal matrix reinforcement of surgical anastomosis. This finding is worthy of further investigation, as reduction of inflammation with anastomotic site reinforcement is a novel finding, and more in-depth research may lead to discoveries on the physiologic role of the surgical anastomosis in post-gastrectomy patients. In addition, lower CRP and NUn scores for the intervention arm suggest potential for larger studies to detect reduction in clinical leak rates after acellular dermal matrix reinforcement.

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).

Comparison of Short-Term Outcomes Using Three-Dimensional and Two-Dimensional Laparoscopic Gastrectomy for Gastric Cancer.

Introduction: This study investigated the oncological and technical advantages of three-dimensional (3D) versus two-dimensional (2D) laparoscopic gastric cancer surgery. Materials and Methods: This study included 68 gastric cancer patients who had undergone laparoscopic distal gastrectomy at Korea University Ansan Hospital (3D group, n = 34; 2D group, n = 34). The surgical outcomes and duration of each phase were compared between the groups. Results: The total operative time with 3D laparoscopy was significantly shorter than with 2D laparoscopy (227.8 ± 39.0 versus 249.6 ± 45.3 minutes; P = .037). There were no significant differences between the groups in the number of gauze pads used, time to first postoperative flatus, and number of harvested lymph nodes (2.0 [1.0-2.0] versus 2.0 [1.0-2.0]; P = .692; 4.0 [4.0-4.0] versus 4.0 [4.0-4.0] days; P = .196; 40.8 ± 16.6 versus 44.0 ± 15.7; P = .412, respectively). The time from omentectomy to right gastric artery ligation and the duration of the reconstruction phase were shorter with 3D than with 2D laparoscopy (62.6 ± 14.5 versus 71.9 ± 18.8 minutes; P = .027; 32.3 ± 7.6 versus 47.7 ± 16.8 minutes; P < .001). Conclusion: In a procedure requiring spatial perception, the operative time was shortened by introducing 3D laparoscopy. Despite the anticipation of a better view for lymph node dissection, the 3D image showed no advantage. Further study may be required by novice surgeons.

Actual compliance to adjuvant chemotherapy in gastric cancer.

PURPOSE: This study aims to investigate the actual compliance with chemotherapy and analyze several factors affecting the compliance in patients with gastric cancer. METHODS: From February 2012 to December 2014, we collected data of patients with gastric cancer who received adjuvant chemotherapy (TS-1 monotherapy or XELOX: capecitabine/oxaliplatin) in Korea. RESULTS: We collected data of 1,089 patients from 31 institutions. The completion rate and dose reduction rate by age (≥60 years vs. <60 years) were 57.5% vs. 76.8% (P < 0.001) and 17.9% vs. 21.3% (P = 0.354); by body mass index (BMI) (≥23 kg/m2 vs. <23 kg/m2) were 70.2% vs. 63.2% (P = 0.019) and 19.2% vs. 19.9% (P = 0.987), respectively. The compliance by American Society of Anesthesiologists physical status (ASA PS) classification was as follows: completion rate was 74.4%, 62.8%, and 60% (P = 0.001) and the dose reduction rate was 18.4%, 20.7%, and 17.8% (P = 0.946) in ASA PS classification I, II, and III, respectively. The completion rate of TS-1 and XELOX was 65.9% vs. 70.3% (P = 0.206) and the dose reduction rate was 15.7% vs. 33.6% (P < 0.001). Furthermore, the completion rate of chemotherapy by surgical oncologists and medical oncologists was 69.5% vs. 63.2% (P = 0.028) and the dose reduction rate was 17.4% vs. 22.3% (P = 0.035), respectively. CONCLUSION: The compliance was lower in patients who were older than 60 years, had BMI <23 kg/m2, and had higher ASA PS classification. Furthermore, the patients showed higher compliance when they received chemotherapy from surgical oncologists rather than from medical oncologists.

Metabolic and Bariatric Surgery Accreditation Program and National Health Insurance System in Korea.

Since the first laparoscopic bariatric surgery in Korea introduced in January 2003, the number of metabolic and bariatric surgery has been steadily increasing. According to the report from National Health Insurance big data analysis, the prevalence of morbid and super obesity has greatly increased and metabolic and bariatric surgery also increased in the last 10 years. As the incidence of morbid obesity is more frequent in people of poor socioeconomic status, the need for a reimbursement by the government seemed to be necessary. Finally, the national health insurance system decided to financially cover metabolic and bariatric surgery from January 2019. In order to improve the safety and qualify of metabolic and bariatric surgery, the Korean Society for Bariatric and Metabolic Surgery (KSMBS) introduced surgeon's and institution's accreditation system. The authors intend to introduce comprehensive overview of accreditation system of bariatric surgery and discuss the contents of national health insurance for metabolic and bariatric surgery.