Does total omentectomy prevent peritoneal seeding for advanced gastric cancer with serosal invasion?

BACKGROUND: Radical gastrectomy is composed of gastrectomy, lymph node dissection, and omentectomy. Total omentectomy (TO) is expected to reduce the incidence of peritoneal recurrence. We aimed to investigate the necessity of TO for advanced gastric cancer (AGC) with serosal invasion. METHODS: We retrospectively reviewed 310 patients who underwent radical gastrectomy with TO and 93 patients who underwent partial omentectomy (PO) for gastric cancer with serosal invasion between August, 2005 and December, 2017. Finally, 91 patients in the PO group and 91 in the TO group were enrolled based on a 1:1 propensity-score matching analysis. We evaluated surgical and oncological outcomes, including 5-year overall and recurrence-free survival rates. RESULTS: There was no statistically significant difference between the two groups in postoperative complications. Recurrence sites showed similar patterns in both groups, including peritoneal recurrence (PO vs. TO, 18.7% vs. 28.6%; p = 0.188). Five-year overall survival was better in the PO group (p = 0.018), while 5-year recurrence-free survival was similar in both groups (p = 0.066). CONCLUSION: TO might not be an essential part of preventing peritoneal recurrence for AGC with serosal invasion. PO could be considered a radical gastrectomy for T4a gastric cancer.

Analysis of risk factors affecting long-term survival in elderly patients with advanced gastric cancer.

BACKGROUND: Factors predicting postoperative complications after gastrectomy for elderly patients with gastric cancer have been analyzed in several previous studies. However, there is limited research available on risk factors related to long-term survival. AIMS: This study aimed to analyze factors affecting long-term survival after curative gastrectomy in elderly patients with advanced gastric cancer. METHODS: This study included patients aged > 75 years with histologically confirmed advanced gastric cancer stage II or greater. Before analysis, risk factors were categorized into four groups: baseline characteristics, underlying diseases, surgical and pathologic factors, and nutritional factors. RESULTS: The mean follow-up duration was 71.0 months. The 5-year overall survival and disease-specific survival rates were 51.5% and 58.3%, respectively. Kaplan-Meier curves showed that patients who were female and overweight had significantly longer survival rates than those who were male and underweight. Elderly patients who underwent a total gastrectomy had poorer survival rates than those who underwent a distal gastrectomy. Multivariate analysis demonstrated that tumor stage, extent of gastrectomy, overweight status and overall complication were independent risk factors for overall survival. DISCUSSION: Our study show that the overweight patients, the extent of gastrectomy, tumor stage and overall complications are significant risk factors affecting long-term survival. CONCLUSIONS: Therefore, surgeons may be cautious in performing total gastrectomy in elderly gastric cancer patients. Additionally, it is important to focus on improving nutritional status and mitigating overall complications.

Safety evaluation of curative gastrectomy for gastric cancer patients who underwent liver transplantation: a comparative study with conventional gastrectomy for gastric cancer patients.

BACKGROUND: We aimed to examine the technical and oncological safety of curative gastrectomy for gastric cancer patients who underwent liver transplantation. METHODS: In this study, we compared the surgical and oncological outcomes of two groups. The first group consisted of 32 consecutive patients who underwent curative gastrectomy for gastric cancer after liver transplantation (LT), while the other group consisted of 127 patients who underwent conventional gastrectomy (CG). In addition, a subgroup analysis was performed to evaluate the impact of the background differences and the surgical outcomes on the involvement of a specialized liver transplant surgery team. RESULTS: The mean operative time was significantly longer in the LT group (p < 0.05). Furthermore, there were more frequent cases of postoperative transfusion in the LT group compared to the CG group (p < 0.05). However, there were no significant differences in the overall complications between the groups (25.00 vs 23.62%, p = 0.874). The 5-year overall survival rates of the LT and CG groups were 76.7% and 90.1%, respectively (p < 0.05). The results of the subgroup analysis demonstrated no statistically significant difference in various early surgical outcomes, such as time to transfusion during surgery, first flatus, time to first soft diet, postoperative complications, hospital stay after surgery, and the number of harvested lymph nodes except for operation time. CONCLUSIONS: Despite one's medical history of undergoing LT, our study demonstrated that curative gastrectomy could be a surgically safe treatment for gastric cancer. However, further study should be conducted to identify the reason gastric cancer patients who underwent liver transplant surgery have lower overall survival rate.

Comparison of Standard D2 and Limited Lymph Node Dissection in Elderly Patients with Advanced Gastric Cancer.

BACKGROUND: Knowledge on the optimal extent of lymphadenectomy among elderly patients with advanced gastric cancer is limited. This study was designed to compare standard D2 and limited lymphadenectomy for evaluating the appropriate extent of lymphadenectomy. PATIENTS AND METHODS: We retrospectively reviewed patient's data based on a prospectively collected gastric cancer registry. The inclusion criteria were age above 75 years and histologically confirmed stage II or more advanced gastric cancer. In this study, 103 patients who underwent limited lymph node dissection and 134 patients who underwent standard D2 lymph node dissection were included to evaluate surgical and oncological outcomes using propensity score matching (PSM) analysis. RESULTS: The mean age after PSM was approximately 78 years in both groups. The Charlson Comorbidity Index was 5.81 ± 0.87 and 5.75 ± 0.76, respectively, and 12.5% of the patients in both groups had American Society of Anesthesiologists scores of more than 3. The limited lymphadenectomy group showed a shorter operation time and fewer retrieved lymph. However, other surgical outcomes and pathological data were not significantly different between the groups. No postoperative mortality within 30 days was observed. There were no significant differences in overall complications between the groups. The 3-year overall survival rates of the limited and standard lymphadenectomy groups were 58.3% and 73.6%, respectively. The 3-year recurrence-free survival rate of the limited lymphadenectomy group was lower than that of the standard lymphadenectomy group; however, the difference was not statistically significant. CONCLUSIONS: Standard D2 lymphadenectomy has better oncological outcomes in elderly patients with advanced gastric cancer.

Novel temperature-responsive hydrogel injected to the incision site for postoperative pain relief in laparoscopic abdominal surgery: a single-blind, randomized, pivotal clinical trial.

BACKGROUND: A temperature-responsive hydrogel (PF-72; TGel Bio, Inc., Ltd, Seoul, Korea), developed as a sustained drug delivery device, can be mixed with ropivacaine to reduce pain in the incision area. The hydrogel is soluble at low temperatures (2-8 °C) and is converted into a gel at high temperatures (> 30 °C). We aimed to evaluate whether the administration of ropivacaine using PF-72 at incision sites reduces pain until 72 h postoperatively in patients undergoing laparoscopic stomach or colorectal surgery. METHODS: Patients were randomly assigned to the control group (0.75% ropivacaine) or PF-72 group (PF-72 mixed with 0.75% ropivacaine). Before surgical incision closure, 0.75% ropivacaine or PF-72 mixed with 0.75% ropivacaine was injected into the subcutaneous fat and muscle of all incisions. Postoperative pain was evaluated by the Numerical Rating Scale (NRS, 0 = no pain, 10 = most severe pain) for wound pain at 3, 6, 24, 48, and 72 h after the end of surgery. RESULTS: Ninety-nine patients (control, n = 51; PF-72, n = 48) were included in the analysis. The areas under the curve of NRS for wound pain until 72 h in the control group and the PF-72 group were 188.7 ± 46.1 and 135.3 ± 49.9 h, respectively (P < 0.001). The frequency of the administration of rescue analgesics in the general ward was similar between the two groups. CONCLUSION: PF-72 mixed with 0.75% ropivacaine reduced postoperative pain until 72 h in patients undergoing laparoscopic surgery. Although the study population was not large enough for safety evaluation, no adverse events associated with PF-72 were observed.

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 changes in the serum metabolome after laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass.

INTRODUCTION: Bariatric surgery is known to be the most effective treatment for weight loss in obese patients and for the rapid remission of obesity-related comorbidities. These short-term improvements result from not only limited digestion or absorption but also dynamic changes in metabolism throughout the whole body. However, short-term metabolism studies associated with bariatric surgery in Asian individuals have not been reported. OBJECTIVES: The aim of this study was to investigate the short-term metabolome changes in the serum promoted by laparoscopic sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) and to determine the underlying mechanisms that affect obesity-related comorbidities. METHODS: Serum samples were collected from Korean patients who underwent RYGB or SG before and 4 weeks after the surgery. Metabolomic and lipidomic profiling was performed using UPLC-Orbitrap-MS, and data were analyzed using statistical analysis. RESULTS: Metabolites mainly related to amino acids, lipids (fatty acids, glycerophospholipids, sphingolipids, glycerolipids) and bile acids changed after surgery, and these changes were associated with the lowering of risk factors for obesity-related diseases such as nonalcoholic fatty liver disease (NAFLD), type 2 diabetes (T2D) and atherosclerosis. Interestingly, the number of significantly altered metabolites related to the lipid metabolism were greater in SG than in RYGB. Furthermore, the metabolites related to amino acid metabolism were significantly changed only after SG, whereas bile acid changed significantly only following RYGB. CONCLUSION: These differences could result from anatomical differences between the two surgeries and could be related to the gut microbiota. This study provides crucial information to expand the knowledge of the common but different molecular mechanisms involved in obesity and obesity-related comorbidities affected by each bariatric procedure.

Role of Resection Following Focal Progression with Standard Doses of Imatinib in Patients with Advanced Gastrointestinal Stromal Tumors: Results of Propensity Score Analyses.

BACKGROUND: There are limited data on the clinical benefits of adding surgical resection in patients with focally progressive gastrointestinal stromal tumor (GIST). This study aims to compare the clinical outcomes of resection plus imatinib dose escalation or maintenance (S group) with imatinib dose escalation alone (NS group) in patients with advanced GIST following focal progression (FP) with standard doses of imatinib. MATERIALS AND METHODS: A total of 90 patients with advanced GISTs who experienced FP with standard doses of imatinib were included in this retrospective analysis. The primary endpoints were time to imatinib treatment failure (TTF) and overall survival (OS). RESULTS: Compared with the NS group (n = 52), patients in the S group (n = 38) had a higher proportion of primary tumor site involvement and lower tumor burden at FP. With a median follow-up duration of 31.0 months, patients in the S group had significantly better TTF and OS than patients in the NS group (median TTF: 24.2 vs. 6.5 months, p < .01; median OS: 53.2 vs. 35.1 months, p = .009). Multivariate analysis showed that S group independently demonstrated better TTF (hazard ratio [HR], 0.29; p < .01) and OS (HR, 0.47; p = .01). Even after applying inverse probability of treatment-weighting adjustments, S group demonstrated significantly better TTF (HR, 0.36; p < .01) and OS (HR, 0.58; p = .049). CONCLUSION: Our results suggested that resection following FP with standard doses of imatinib in patients with advanced GIST provides additional benefits over imatinib dose escalation alone. IMPLICATIONS FOR PRACTICE: This is the first study to compare the clinical outcomes of resection plus imatinib dose escalation or maintenance (S group) with imatinib dose escalation alone (NS group) in patients with advanced gastrointestinal stromal tumor (GIST) following focal progression (FP) with standard doses of imatinib. These findings suggest that resection can be safely performed following FP, and the addition of surgical resection provides further clinical benefit over imatinib dose escalation alone. Based on these results, the authors recommend resection following FP in patients with advanced GIST provided that an experienced multidisciplinary team is involved in the patient's treatment.

Sporadic Early-Onset Diffuse Gastric Cancers Have High Frequency of Somatic CDH1 Alterations, but Low Frequency of Somatic RHOA Mutations Compared With Late-Onset Cancers.

BACKGROUND & AIMS: Early-onset gastric cancer, which develops in patients younger than most gastric cancers, is usually detected at advanced stages, has diffuse histologic features, and occurs more frequently in women. We investigated somatic genomic alterations associated with the unique characteristics of sporadic diffuse gastric cancers (DGCs) from younger patients. METHODS: We conducted whole exome and RNA sequence analyses of 80 resected DGC samples from patients 45 years old or younger in Korea. Patients with pathogenic germline mutations in CDH1, TP53, and ATM were excluded from the onset of this analysis, given our focus on somatic alterations. We used MutSig2CV to evaluate the significance of mutated genes. We recruited 29 additional early-onset Korean DGC samples and performed SNP6.0 array and targeted sequencing analyses of these 109 early-onset DGC samples (54.1% female, median age, 38 years). We compared the SNP6.0 array and targeted sequencing data of the 109 early-onset DGC samples with those from diffuse-type stomach tumor samples collected from 115 patients in Korea who were 46 years or older (late onset) at the time of diagnosis (controls; 29.6% female, median age, 67 years). We compared patient survival times among tumors from different subgroups and with different somatic mutations. We performed gene silencing of RHOA or CDH1 in DGC cells with small interfering RNAs for cell-based assays. RESULTS: We identified somatic mutations in the following genes in a significant number of early-onset DGCs: the cadherin 1 gene (CDH1), TP53, ARID1A, KRAS, PIK3CA, ERBB3, TGFBR1, FBXW7, RHOA, and MAP2K1. None of 109 early-onset DGC cases had pathogenic germline CDH1 mutations. A higher proportion of early-onset DGCs had mutations in CDH1 (42.2%) or TGFBR1 (7.3%) compared with control DGCs (17.4% and 0.9%, respectively) (P < .001 and P = .014 for CDH1 and TGFBR1, respectively). In contrast, a smaller proportion of early-onset DGCs contained mutations in RHOA (9.2%) than control DGCs (19.1%) (P = .033). Late-onset DGCs in The Cancer Genome Atlas also contained less frequent mutations in CDH1 and TGFBR1 and more frequent RHOA mutations, compared with early-onset DGCs. Early-onset DGCs from women contained significantly more mutations in CDH1 or TGFBR1 than early-onset DGCs from men. CDH1 alterations, but not RHOA mutations, were associated with shorter survival times in patients with early-onset DGCs (hazard ratio, 3.4; 95% confidence interval, 1.5-7.7). RHOA activity was reduced by an R5W substitution-the RHOA mutation most frequently detected in early-onset DGCs. Silencing of CDH1, but not RHOA, increased migratory activity of DGC cells. CONCLUSIONS: In an integrative genomic analysis, we found higher proportions of early-onset DGCs to contain somatic mutations in CDH1 or TGFBR1 compared with late-onset DGCs. However, a smaller proportion of early-onset DGCs contained somatic mutations in RHOA than late-onset DGCs. CDH1 alterations, but not RHOA mutations, were associated with shorter survival times of patients, which might account for the aggressive clinical course of early-onset gastric cancer. Female predominance in early-onset gastric cancer may be related to relatively high rates of somatic CDH1 and TGFBR1 mutations in this population.

Discovery of gastric cancer specific biomarkers by the application of serum proteomics.

Current diagnostic markers for gastric cancer are not sufficiently specific or sensitive for use in clinical practice. The aims of this study are to compare the proteomes of serum samples from patients with gastric cancers and normal controls, and to develop useful tumor markers of gastric cancer by quantitative proteomic analysis. We identified a total of 388 proteins with a ≤1% FDR and with at least two unique peptides from the sera of each group. Among them, 215, 251, and 260 proteins were identified in serum samples of patients in an advanced cancer group, early cancer group, and normal control group, respectively. We selected differentially expressed proteins in cancer patients compared with those of normal controls via semiquantitative analyses comparing the spectral counts of identified proteins. These differentially expressed proteins were successfully verified using an MS-based quantitative assay, multiple reactions monitoring analysis. Four proteins (vitronectin, clusterin isoform 1, thrombospondin 1, and tyrosine-protein kinase SRMS) were shown to have significant changes between the cancer groups and the normal control group. These four serum proteins were able to discriminate gastric cancer patients from normal controls with sufficient specificity and selectivity.

Comparison of long-term survival and immediate postoperative liver function after laparoscopic and open distal gastrectomy for early gastric cancer patients with liver cirrhosis.

BACKGROUND: Several studies have suggested no difference in the liver function of early gastric cancer (EGC) patients with liver cirrhosis (LC) between laparoscopic and open distal gastrectomy. However, the number of patients and comparison of long-term survival rates between the two groups are limited. The purpose of this study was to compare the long-term survival and immediate postoperative liver function of EGC patients with LC after laparoscopic and open distal gastrectomy. MATERIALS AND METHODS: The clinical data of EGC patients with LC who had no other malignancy and underwent distal gastrectomy at Asan Medical Center between January 2005 and April 2013 were investigated retrospectively. All patients were divided into two groups: the open group (OG) and laparoscopic group (LG). The clinicopathologic data of the two groups were compared. RESULTS: The number of patients in each group was 48 and 27 in the OG and LG, respectively. There were no significant differences in the age, sex ratio, ASA score, cause of liver cirrhosis, preoperative Child-Pugh classification, tumor location, TNM stage, total postoperative drain amount, albumin, total bilirubin, alkaline phosphatase, alanine aminotransferase, prothrombin time, morbidity and recurrence rate. Shorter hospital stay, longer operative time and more retrieved lymph nodes were observed in LG. The long-term overall survival rate was not different between the two groups (P = 0.356). CONCLUSIONS: For EGC patients with liver cirrhosis, especially Child A cirrhosis, laparoscopic or laparoscopy-assisted distal gastrectomy can be a safe surgical procedure in comparison to open distal gastrectomy in terms of the long-term survival rate and immediate postoperative liver function.

Phase 2 study of adjuvant chemotherapy with docetaxel, capecitabine, and cisplatin in patients with curatively resected stage IIIB-IV gastric cancer.

OBJECTIVE: Postoperative chemotherapy with S-1 or capecitabine plus oxaliplatin is a standard treatment for resectable gastric cancer (GC). However, survival outcomes of stage IIIB-IV (M0) GC cases are still poor. We investigated the efficacy and safety of docetaxel, capecitabine, and cisplatin (DXP) in patients with stage IIIB-IV GC. METHODS: This was a single-arm phase 2 study that included patients with stage IIIB-IV GC who underwent D2 gastrectomy. Patients received six cycles of docetaxel [60 mg/m2 on day 1 (D1)], capecitabine (1,875 mg/m2/day on D1-14), and cisplatin (60 mg/m2 on D1) every 3 weeks. The primary end-point was recurrence-free survival (RFS). RESULTS: A total of 46 GC patients between January 2007 and August 2008 were included. After a median follow-up of 56.1 months (range 52.2-64.1), the median RFS and overall survival (OS) were 26.9 months (95 % CI 7.5-46.4) and 43.9 months (95 % CI 29.2-58.7), respectively. The 5-year RFS and OS rates were 39.1 and 41.3 %, respectively. The most common grade 3/4 toxicities were neutropenia (40 %), anorexia (22 %), and febrile neutropenia (15 %). CONCLUSIONS: Adjuvant DXP is feasible and effective for patients with stage IIIB-IV GC. A phase 3 study comparing triplet and doublet regimens for these patients is ongoing.

Phase I/II study of a combination of capecitabine, cisplatin, and intraperitoneal docetaxel (XP ID) in advanced gastric cancer patients with peritoneal metastasis.

BACKGROUND: This study was conducted to determine the recommended dose (RD) of intraperitoneal docetaxel (ID) in combination with systemic capecitabine and cisplatin (XP) and to evaluate its efficacy and safety at the RD in advanced gastric cancer (AGC) patients with peritoneal metastasis. METHODS: AGC patients with peritoneal metastasis received XP ID, which consists of 937.5 mg/m2 of capecitabine twice daily on days 1-14, 60 mg/m2 of intravenous cisplatin on day 1, and intraperitoneal docetaxel at 3 different dose levels (60, 80, or 100 mg/m2) on day 1, every 3 weeks. In the phase I study, the standard 3 + 3 method was used to determine the RD of XP ID. In the phase II study, patients received RD of XP ID. RESULTS: In the phase I study, ID 100 mg/m2 was chosen as the RD, with one dose-limiting toxicity (ileus) out of six patients. The 39 AGC patients enrolled in the phase II study received the RD of XP ID. The median progression-free survival was 11.0 months (95% CI 6.9-15.1), and median overall survival was 15.1 months (95% CI 9.1-21.1). The most frequent grade 3/4 adverse events were neutropenia (38.6%) and abdominal pain (30.8%). The incidence of abdominal pain cumulatively increased in the later treatment cycles. CONCLUSIONS: Our study indicated that XP ID was effective, with manageable toxicities, in AGC patients with peritoneal metastasis. As the cumulative incidence of abdominal pain was probably related to bowel irritation by ID, it might be necessary to modify the dose.

Associations between CYP2A6 polymorphisms and outcomes of adjuvant S-1 chemotherapy in patients with curatively resected gastric cancer.

BACKGROUND: Oral fluoropyrimidine S-1 contains tegafur, which is metabolized to 5-fluorouracil by cytochrome P450 2A6 (CYP2A6). We here examined associations between CYP2A6 polymorphisms and treatment outcomes of adjuvant S-1 in gastric cancer patients. METHODS: Patients received adjuvant S-1 (40 mg/m2 twice daily, days 1-28, every 6 weeks for eight cycles) after curative surgery for pathological stage II-III gastric cancer. We analyzed the wild-type allele (W) (CYP2A6*1) and four variant alleles (V) (CYP2A6*4, *7, *9, *10) that abolish or reduce this enzyme activity. RESULTS: Patients (n = 200) were enrolled between November 2007 and July 2013 with the following clinical characteristics: median age, 57 years (range, 32-83 years); 128 men, 72 women. With a median follow-up of 46.4 months, the 3-year relapse-free survival (RFS) and overall survival (OS) rates were 83.1 % (95 % CI, 77.7-88.5 %) and 94.8 % (95 % CI, 91.6-98.0 %), respectively. Genotype distributions were as follows: W/W (n = 49, 24.5 %), W/V (n = 94, 47.0 %), and V/V (n = 57, 28.5 %). Overall toxicity did not differ according to genotype for any grade (p = 0.612) or grade ≥3 (p = 0.143). However, RFS differed significantly according to CYP2A6 genotype. The 3-year RFS rates were 95.9 % for W/W, 83.1 % for W/V, and 72.5 % for V/V (p = 0.032). Carriers of W/V and V/V genotypes had a poorer RFS with a hazard ratio of 3.41 (95 % CI, 1.01-11.52; p = 0.049) and 4.03 (95 % CI, 1.16-13.93; p = 0.028), respectively, compared with the W/W genotype. CONCLUSIONS: CYP2A6 polymorphisms are not associated with toxicity of S-1 chemotherapy, but correlate with the efficacy of S-1 in the adjuvant setting for gastric cancer.

Comparison of long-term outcomes of endoscopic submucosal dissection and surgery for esophagogastric junction adenocarcinoma.

BACKGROUND: Endoscopic submucosal dissection (ESD) has become accepted as the standard treatment for early gastric cancer. However, comparative outcomes of ESD and surgery have not been evaluated for adenocarcinoma in the esophagogastric junction (EGJ). We investigated the long-term outcomes of ESD compared with those of surgery for adenocarcinoma in the EGJ. METHODS: Patients who underwent ESD or surgery for Siewert type II adenocarcinoma between 2005 and 2010 and who met the absolute and expanded criteria for endoscopic resection were eligible. Clinical features and treatment outcomes were retrospectively reviewed using medical records. RESULTS: Of the 79 patients included, 40 underwent ESD and 39 underwent surgery. During the median follow-up period of 60.9 months (range, 13.1-125.4 months), the 5-year overall survival rates were 93.9% and 97.3% for the ESD and surgery groups, respectively (p = 0.376). There were no gastric cancer-related deaths in either group. Adverse events occurred in 11 patients (13.9%) overall, and the incidence of treatment-related adverse events was similar between the two groups (10.0% vs. 17.9%, p = 0.308). CONCLUSIONS: ESD may be an effective alternative to surgery for the treatment of early gastric cancer in the EGJ based on the comparable long-term outcomes.

Overlapping self-expandable metallic stent for palliation of a long (>10 cm) malignant gastroduodenal obstruction.

Background Self-expandable metallic stent (SEMS) placement is a well-established palliative treatment approach for malignant gastroduodenal obstruction. In patients with a long (>10 cm) stricture, multiple stents placed in an overlapping fashion are often required. Purpose To investigate the outcomes of overlapping SEMS placement for the palliative treatment of malignant gastroduodenal obstruction in patients with a long (>10 cm) stricture. Material and Methods The medical records of 40 patients who underwent fluoroscopic overlapping SEMS placement for malignant gastroduodenal obstruction due to a long (>10 cm) stricture were reviewed. Results The technical and clinical success rates were 100% and 65.0%, respectively. The mean length of the stricture was 17.0 ± 4.7 cm and the mean number of stents placed in each patient was 2.2 ± 0.5. Metastatic cancer (odds ratio [OR], 0.315; P = 0.018), Eastern Cooperative Oncology Group (ECOG) score ≥3 (OR, 0.018; P = 0.006), and carcinomatosis with ascites (OR, 0.025; P = 0.017) were independent predictors of poor clinical success. The rates of minor and major complications were 27.5% and 2.5%, respectively. The median stent patency and survival were 33 days (interquartile range [IQR], 19-60 days) and 35 days (IQR, 19-73 days), respectively. An ECOG score ≥3 was an independent predictor of a poor survival outcome (hazard ratio, 4.681; P < 0.001). Conclusion Overlapping SEMS placement may be safe and effective for the palliative treatment of malignant gastroduodenal obstruction in patients with a long (>10 cm) stricture.

Effect of Intravenous Ferric Carboxymaltose on Hemoglobin Response Among Patients With Acute Isovolemic Anemia Following Gastrectomy: The FAIRY Randomized Clinical Trial.

IMPORTANCE: Acute isovolemic anemia occurs when blood loss is replaced with fluid. It is often observed after surgery and negatively influences short-term and long-term outcomes. OBJECTIVE: To evaluate the efficacy and safety of ferric carboxymaltose to treat acute isovolemic anemia following gastrectomy. DESIGN, SETTING, AND PARTICIPANTS: The FAIRY trial was a patient-blinded, randomized, phase 3, placebo-controlled, 12-week study conducted between February 4, 2013, and December 15, 2015, in 7 centers across the Republic of Korea. Patients with a serum hemoglobin level of 7 g/dL to less than 10 g/dL at 5 to 7 days following radical gastrectomy were included. INTERVENTIONS: Patients were randomized to receive a 1-time or 2-time injection of 500 mg or 1000 mg of ferric carboxymaltose according to body weight (ferric carboxymaltose group, 228 patients) or normal saline (placebo group, 226 patients). MAIN OUTCOMES AND MEASURES: The primary end point was the number of hemoglobin responders, defined as a hemoglobin increase of 2 g/dL or more from baseline, a hemoglobin level of 11 g/dL or more, or both at week 12. Secondary end points included changes in hemoglobin, ferritin, and transferrin saturation levels over time, percentage of patients requiring alternative anemia management (oral iron, transfusion, or both), and quality of life at weeks 3 and 12. RESULTS: Among 454 patients who were randomized (mean age, 61.1 years; women, 54.8%; mean baseline hemoglobin level, 9.1 g/dL), 96.3% completed the trial. At week 12, the number of hemoglobin responders was significantly greater for ferric carboxymaltose vs placebo (92.2% [200 patients] for the ferric carboxymaltose group vs 54.0% [115 patients] for the placebo group; absolute difference, 38.2% [95% CI, 33.6%-42.8%]; P = .001). Compared with the placebo group, patients in the ferric carboxymaltose group experienced significantly greater improvements in serum ferritin level (week 12: 233.3 ng/mL for the ferric carboxymaltose group vs 53.4 ng/mL for the placebo group; absolute difference, 179.9 ng/mL [95% CI, 150.2-209.5]; P = .001) and transferrin saturation level (week 12: 35.0% for the ferric carboxymaltose group vs 19.3% for the placebo group; absolute difference, 15.7% [95% CI, 13.1%-18.3%]; P = .001); but there were no significant differences in quality of life. Patients in the ferric carboxymaltose group required less alternative anemia management than patients in the placebo group (1.4% for the ferric carboxymaltose group vs 6.9% for the placebo group; absolute difference, 5.5% [95% CI, 3.3%-7.6%]; P = .006). The total rate of adverse events was higher in the ferric carboxymaltose group (15 patients [6.8%], including injection site reactions [5 patients] and urticaria [5 patients]) than the placebo group (1 patient [0.4%]), but no severe adverse events were reported in either group. CONCLUSION AND RELEVANCE: Among adults with isovolemic anemia following radical gastrectomy, the use of ferric carboxymaltose compared with placebo was more likely to result in improved hemoglobin response at 12 weeks. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01725789.

Over-the-wire versus through-the-scope stents for the palliation of malignant gastric outlet obstruction: A retrospective comparison study.

OBJECTIVES: To compare the outcomes of over-the-wire (OTW) and through-the-scope (TTS) partially covered stents in patients with malignant gastric outlet obstruction (GOO). METHODS: A retrospective study was performed in 306 patients who had either OTW (n = 125) or TTS (n = 181) stents placed. Outcomes analysed included technical and clinical success, procedure time, complications, re-intervention, stent patency and survival. RESULTS: One hundred and ninety-three patients met our inclusion criteria, including 125 patients in the OTW group and 68 patients in the TTS group. Technical and clinical outcomes were similar in the two groups. Stent migration rate was higher in the TTS than in the OTW group (P = 0.002) and was associated with straight stent and subsequent chemotherapy in the TTS group. Stent collapse was lower in the TTS than in the OTW group (P = 0.021). Six-month stent patency rate was higher in the OTW than in the TTS group (P = 0.044). CONCLUSIONS: TTS and OTW stents for the palliation of malignant GOO resulted in similar technical and clinical outcomes, stent patency and survival. TTS stents were associated with a higher migration rate, especially use of straight stents and subsequent chemotherapy, but a lower stent collapse rate than OTW stents. KEY POINTS: • OTW and TTS stents are equally effective in palliating GOO symptoms. • Six-month stent patency was higher for OTW than for TTS. • The straight stent and subsequent chemotherapy could increase stent migration. • Complication rates were lower for flared than for straight stents. • It is necessary to develop a multidisciplinary approach to integrate clinical experience.

Gastroduodenal stent placement versus surgical gastrojejunostomy for the palliation of gastric outlet obstructions in patients with unresectable gastric cancer: a propensity score-matched analysis.

OBJECTIVES: To compare the outcomes between stent placement and surgical gastrojejunostomy (GJ) for the palliation of gastric outlet obstruction (GOO) in patients with unresectable gastric cancer. METHODS: A retrospective study was performed in a single university hospital in 224 patients with GOO, and who were treated either by stent placement (n = 124) or surgical GJ (n = 100). The outcomes were assessed with reference to the following variables with the use of propensity-score matching: success rates; complications; dysphagia scores, albumin, and body mass index; survival; symptom-free duration; and hospitalization. RESULTS: We identified a well-balanced cohort of 74 pairs of patients, matched on the basis of propensity score. The dysphagia score 7 days after treatment was significantly better in the stent group (P < 0.001). Albumin level 1 month after treatment was significantly lower in the stent group (P < 0.001). Symptom-free duration and hospitalization were significantly longer in the surgery group (P = 0.002, P < 0.001, respectively). The recurrence rate was significantly higher in the stent group (P = 0.032). CONCLUSIONS: Stent placement can provide faster symptom relief and shorter hospitalization, while surgical GJ can provide longer symptom-free duration, less recurrent obstruction symptoms and better nutritional status. KEY POINTS: • The two methods are equally effective in palliating gastric outlet obstruction symptoms • The stent group showed rapid and efficient palliation of symptoms • Recurrent symptoms were more frequent in the stent group • Surgical gastrojejunostomy provides a longer symptom-free duration and better nutritional status.