5-year follow-up results of a JCOG1104 (OPAS-1) phase III non-inferiority trial to compare 4 courses and 8 courses of S-1 adjuvant chemotherapy for pathological stage II gastric cancer.

BACKGROUND: Postoperative adjuvant chemotherapy with S-1 for 1 year (corresponding to eight courses) is the standard treatment for pathological stage II gastric cancer. The phase III trial (JCOG1104) investigating the non-inferiority of four courses of S-1 to eight courses was terminated due to futility at the first interim analysis. To confirm the primary results, we reported the results after a 5-years follow-up in JCOG1104. METHODS: Patients histologically diagnosed with stage II gastric cancer after radical gastrectomy were randomly assigned to receive S-1 for eight or four courses. In detail, 80 mg/m2/day S-1 was administered for 4 weeks followed by a 2-week rest as a single course. RESULTS: Between February 16, 2012, and March 19, 2017, 590 patients were enrolled and randomly assigned to 8-course (295 patients) and 4-course (295 patients) regimens. After a 5-years follow-up, the relapse-free survival at 3 years was 92.2% for the 8-course arm and 90.1% for the 4-course arm, and that at 5 years was 87.7% for the 8-course arm and 85.6% for the 4-course arm (hazard ratio 1.265, 95% CI 0.846-1.892). The overall survival at 3 years was 94.9% for the 8-course arm, 93.2% for the 4-course arm, and that at 5 years was 89.7% for the 8-course arm, and 88.6% for the 4-course arm (HR 1.121, 95% CI 0.719-1.749). CONCLUSIONS: The survival of the four-course arm was slightly but consistently inferior to that of the eight-course arm. Eight-course S-1 should thus remain the standard adjuvant chemotherapy for pathological stage II gastric cancer.

A multi-institutional prospective observational study to compare postoperative quality of life of patients who undergo total or proximal gastrectomy for early gastric cancer (CCOG1602).

BACKGROUND: Proximal gastrectomy (PG) has become an increasingly preferred procedure for treating early cancer in the upper third of the stomach. However, advantages of PG in postoperative quality of life (QOL) over total gastrectomy (TG) has not fully proven. METHODS: We conducted a multi-institutional prospective observational study (CCOG1602) of patients who undergo TG or PG for cStage I gastric cancer. We used the PGSAS-37 and EORTC-QLQ-C30 to evaluate the changes in body weight and QOL over a 3-year postoperative period. The primary endpoint was the weight loss rate 3 years after surgery. RESULTS: We enrolled 109 patients from 18 institutions and selected 65 and 19 patients for inclusion in the TG and PG groups, respectively. Mean postoperative weight loss rates were 16.0% and 11.7% for the TG and PG groups, respectively (p = 0.056, Cohen's d 0.656) during postoperative year 1% and 15.0% and 10.8% for TG and PG (p = 0.068, Cohen's d 0.543), respectively, during postoperative year 3, indicating that the PG group achieved a better trend with a moderate effect size. According to the PGSAS-37, the PG group experienced a better trend in the indigestion subscale (p < 0.001, Cohen's d -1.085) and total symptom score (p = 0.050, Cohen's d -0.59) during postoperative year 3 compared with the TG group. In contrast, the EORTC-QLQ-C30 detected no difference between the groups at any time point during 3-year postoperative period. CONCLUSIONS: This prospective study demonstrates that PG tended to be more favorable compared with TG with respect to postoperative weight loss and QOL, particularly regarding indigestion.

The long-term quality of life after distal and pylorus-preserving gastrectomy for stage I gastric cancer: A prospective multi-institutional study (CCOG1601).

PURPOSE: While regarded as function-preserving gastrectomy, few prospective longitudinal clinical trials have addressed the postoperative quality of life (QOL) after pylorus-preserving gastrectomy (PPG). We prospectively compared chronological changes in postoperative body weight and the QOL between PPG and distal gastrectomy (DG) for pathological Stage I gastric cancer (GC). METHODS: We conducted a multi-institutional prospective study (CCOG1601) to evaluate patients who underwent DG and PPG. The QOL was examined using the European Organization for Research and Treatment of Cancer Quality of life questionnaire-C30 (EORTC QLQ-C30) and the Post-Gastrectomy Syndrome Assessment Scale-37 (PGSAS-37). A total of 295 patients were enrolled from 15 institutions, and propensity score matching was performed to adjust for the essential variables for comparison analyses. RESULTS: After propensity score matching, 25 pairs of patients were identified. In the first postoperative month, DG achieved a superior nausea and vomiting score (EORTC QLQ-C30) and meal-related distress, indigestion, and dumping scores (PGSAS-37). No significant differences were noted between DG and PPG in the long-term QOL. Postoperative body weight loss was similar in both groups. CONCLUSIONS: This prospective observational study failed to demonstrate the superiority of PPG over DG in terms of postoperative body weight changes and the QOL.

Endoscope Automation Framework with Hierarchical Control and Interactive Perception for Multi-Tool Tracking in Minimally Invasive Surgery.

In the context of Minimally Invasive Surgery, surgeons mainly rely on visual feedback during medical operations. In common procedures such as tissue resection, the automation of endoscopic control is crucial yet challenging, particularly due to the interactive dynamics of multi-agent operations and the necessity for real-time adaptation. This paper introduces a novel framework that unites a Hierarchical Quadratic Programming controller with an advanced interactive perception module. This integration addresses the need for adaptive visual field control and robust tool tracking in the operating scene, ensuring that surgeons and assistants have optimal viewpoint throughout the surgical task. The proposed framework handles multiple objectives within predefined thresholds, ensuring efficient tracking even amidst changes in operating backgrounds, varying lighting conditions, and partial occlusions. Empirical validations in scenarios involving single, double, and quadruple tool tracking during tissue resection tasks have underscored the system's robustness and adaptability. The positive feedback from user studies, coupled with the low cognitive and physical strain reported by surgeons and assistants, highlight the system's potential for real-world application.

Prognostic Significance of Intraoperative Peritoneal Lavage Cytology in Patients with Pancreatic Ductal Adenocarcinoma: A Single-Center Experience and Systematic Review of the Literature.

BACKGROUND: The prognostic significance of peritoneal lavage cytology (PLC) in patients with pancreatic ductal adenocarcinoma (PDAC) remains controversial. The purpose of this study was to evaluate the prognostic impact of PLC status in PDAC patients. METHODS: Patients intending to undergo resection for PDAC between 2007 and 2020 were included. Survival was compared among patients who underwent resection with negative or positive PLC status and those who did not undergo resection. Univariable and multivariable analyses were conducted to evaluate the prognostic impact of positive PLC status. A systematic literature review was performed to evaluate the correlation between prognosis and the positive PLC rate. RESULTS: A total of 480 patients formed the study cohort and were divided as follows: 438 in the negative PLC group, 18 in the positive PLC group, and 24 in the no resection group. Although the median survival time significantly differed between the negative and positive PLC groups (35.7 vs. 13.6 months, P < 0.001), it did not significantly differ between the positive PLC and no resection groups (13.6 vs. 12.2 months, P = 0.605). Multivariable analyses demonstrated that positive PLC status (hazard ratio = 3.54, 95% confidence interval = 1.97-6.38, P < 0.001) was the strongest poor prognostic factor. Based on statistical analyses for the systematic review, the prognostic impact of positive PLC status weakened significantly as the institutional positive PLC rate increased (P = 0.044). CONCLUSIONS: Resection did not improve the prognosis of patients with positive PLC status in our cohort. The institutional positive PLC rate may be a good reference for surgical indication in these patients.

Negative impact of intraoperative blood loss on long-term outcome after curative gastrectomy for advanced gastric cancer: exploratory analysis of the JCOG1001 phase III trial.

BACKGROUND: Recent retrospective studies have shown that increased intraoperative blood loss (IBL) during curative gastrectomy for patients with advanced gastric cancer is a negative prognostic indicator for recurrence. However, there are no reliable reports assessing this with a large-scale prospective cohort. This study aimed to evaluate the impact of IBL on long-term outcomes using data from the JCOG1001 phase III trial, which was designed to determine if bursectomy led to improved survival vs. nonbursectomy in patients with cT3/4a gastric cancer. METHODS: This study included 1203 of the 1204 patients enrolled in the JCOG1001. From the tertiles of IBL (196 ml, 400 ml), we divided the patients into three groups: IBL < 200 ml representing small blood loss (SBL, n = 404), 200 ml ≤ IBL < 400 ml representing medium blood loss (MBL, n = 393), and IBL ≥ 400 ml representing large blood loss (LBL, n = 406). The impact of IBL on relapse-free survival (RFS) was evaluated with univariable comparisons and multivariable Cox regression analyses. RESULTS: Three-year RFS after SBL, MBL, and LBL was 81.7%, 74.8%, and 70.6%, respectively. Multivariable analysis identified IBL, Eastern Cooperative Oncology Group performance status, pT, pN, and postoperative adjuvant chemotherapy as independent predictors of RFS. Compared with SBL as a reference, the hazard ratios of MBL and LBL were 1.461 (P = 0.012) and 1.520 (P = 0.009), respectively. CONCLUSIONS: Based on the analysis of data from a large-scale prospective study, an IBL of ≥ 200 ml after curative surgery for patients with cT3/4a gastric cancer was an independent predictor of reduced RFS.

Impact of tumor-related factors and inter-institutional heterogeneity on preoperative T staging for gastric cancer.

Background: To improve the diagnostic accuracy of preoperative T staging in gastric cancer, the authors evaluated tumor-related factors that might affect the diagnosis. Materials & methods: The authors analyzed the data of cT2-4b gastric cancer patients enrolled in the prospective, multicenter JCOG1302A study. They used contrast-enhanced computed tomography to analyze the association between tumor-related factors and the diagnostic accuracy of T3-4b staging for gastric cancer. Results: Among 876 cT3-4b tumors, the diagnostic accuracy was relatively low in the lower third of the stomach compared with those in the upper or middle. A multivariable analysis revealed that accuracy was higher in the lesser curvature or entire circumference region than in other areas (p < 0.001), in macroscopic types 3/5 than in types 0/1/2 (p = 0.003) and in the undifferentiated histological type than in the differentiated type (p = 0.011). Conclusion: The authors found tumor-related factors affecting preoperative T staging by enhanced computed tomography.

Additional chemotherapy before surgery is expected to have potentially beneficial effects on prognosis compared with chemotherapy only after surgery for advanced gastric cancer. The consideration of chemotherapy before surgery depends on preoperative diagnosis of the depth of tumor invasion in the stomach wall. Overdiagnosis of the depth of tumor invasion may lead to unnecessary administration of chemotherapy that is harmful to the patient. Tumor-related factors such as tumor location, macroscopic type and histological type may affect the diagnosis. Therefore, these factors should be considered with special care for the diagnosis, which may lead to higher accuracy in diagnosing the depth of tumor invasion in gastric cancer.

Validation study of a skill assessment tool for education and outcome prediction of laparoscopic distal gastrectomy.

BACKGROUND: The Japanese operative-rating scale for laparoscopic distal gastrectomy (JORS-LDG) was developed through cognitive task analysis together with the Delphi method to measure intraoperative performance during laparoscopic distal gastrectomy. This study aimed to investigate the value of this rating scale as an educational tool and a surgical outcome predictor in laparoscopic distal gastrectomy. METHODS: The surgical performance of laparoscopic distal gastrectomy was assessed by the first assistant, through self-evaluation in the operating room and by video raters blind to the case. We evaluated inter-rater reliability, internal consistency, and correlations between the JORS-LDG scores and the evaluation methods, patient characteristics, and surgical outcomes. RESULTS: Fifty-four laparoscopic distal gastrectomy procedures performed by 40 surgeons at 16 institutions were evaluated in the operating room and with video recordings using the proposed rating scale. The video inter-rater reliability was > 0.8. Participating surgeons were divided into the low, intermediate, and high groups based on their total scores. The number of laparoscopic surgeries and laparoscopic gastrectomy procedures performed differed significantly among the groups according to laparoscopic distal gastrectomy skill levels. The low, intermediate, and high groups also differed in terms of median operating times (311, 266, and 229 min, respectively, P < 0.001), intraoperative complication rates (27.8, 11.8, and 0%, respectively, P = 0.01), and postoperative complication rates (22.2, 0, and 0%, respectively, P = 0.002). CONCLUSIONS: The JORS-LDG is a reliable and valid measure for laparoscopic distal gastrectomy training and could be useful in predicting surgical outcomes.

A Randomized Phase II Study to Evaluate Prolonged Prophylactic Antibacterial Drug Treatment for Patients with Elevated Drain Amylase Concentration After Gastrectomy with D2 Lymph Node Dissection (REDUCED2).

INTRODUCTION: After D2 gastrectomy for advanced gastric cancer, patients with a high drainage fluid amylase level (d-AMY) on the first postoperative day (1POD) have an especially high risk of severe abdominal infectious complications (AICs), which could be fatal. On the hypothesis that prolonged antibiotic administration could reduce the incidence of severe AICs, we conducted a randomized phase II study to evaluate the optimal treatment duration of prophylactic antibiotics for patients who underwent D2 gastrectomy and had elevated d-AMY on 1POD. METHODS: Patients whose d-AMY was >3000 IU/L on 1POD after D2 gastrectomy for gastric cancer were randomly assigned to normal prophylactic antibiotic treatment given only on the day of surgery (Group A) or to prolonged antibiotic treatment given for 1 week after surgery (Group B). The primary endpoint was the incidence of severe AICs (Clavien-Dindo grade IIIa or higher). This trial was registered as UMIN000012152. RESULTS: This study was started in December 2013 and stopped in February 2019 because of poor patient accrual. Finally, 35 and 37 patients were assigned to groups A and B, respectively. The incidences of AICs were 22.9% (eight of 35) in group A and 13.5% (five of 37) in group B. One-sided P value of the Fisher exact test was 0.234. No adverse reactions to antibiotic prophylaxis were observed in any of the patients. CONCLUSIONS: Prolonged prophylactic antibiotic administration had a marginal benefit in preventing grade III or higher AICs and caused no treatment-related morbidities.

Aggressive and frequent resection of recurrences in retroperitoneal sarcoma contributes to long-term survival.

PURPOSE: Retroperitoneal sarcoma (RPS) is a rare tumor with a poor prognosis and is often undetected until it is significantly enlarged. While surgical resection remains the primary treatment, there is little research on its benefits, especially that concerning the reoperation of recurrent disease. This study investigated the impact of surgical procedures, especially reoperation of recurrent RPS, on prognosis. METHODS: This retrospective study included 51 patients who underwent radical resection surgery (R0 status) for primary or recurrent RPS without distant metastasis. Patient outcomes and prognosis were defined in terms of the clinicopathologic factors and surgical techniques performed. RESULTS: In all cases, the 5-year disease-free survival (DFS) rate was 28.2%, 5-year overall survival rate was 89.9%, and 5-year no residual liposarcoma rate was 54.3% after operation and re-reoperation. There was a statistically significant difference between the 5-year DFS rate and 5-year no residual liposarcoma rate due to frequent re-reoperation (p = 0.011). On univariate analysis of primary and recurrent lesions, the histological type and the number of organs involved were identified as statistically significant prognostic factors. Patients with well-differentiated liposarcomas had a statistically better prognosis than those with other cancer types (primary RPS, p = 0.028; recurrence, p = 0.024). CONCLUSIONS: Aggressive and frequent resection of recurrent RPS with combined resection of adjacent organs contributes to long-term survival. The establishment of a surgical strategy for RPS will require a prospective study.

Survival Outcomes of Two Phase 2 Studies of Adjuvant Chemotherapy with S-1 Plus Oxaliplatin or Capecitabine Plus Oxaliplatin for Patients with Gastric Cancer After D2 Gastrectomy.

BACKGROUND: Two phase 2 trials of oxaliplatin-containing adjuvant therapy for patients with gastric cancer (GC) after D2 gastrectomy were conducted in Japan. The SOXaGC trial evaluated the tolerability and safety of adjuvant therapy with S-1 plus oxaliplatin (SOX), whereas the J-CLASSIC trial evaluated the feasibility of adjuvant therapy with capecitabine plus oxaliplatin (CAPOX). Because both were studies that did not evaluate survival results as study end points, the authors evaluated the survival outcomes for the patients in the two trials. METHODS: All 62 and 100 patients in the full analysis set of the SOXaGC and J-CLASSIC trials, respectively, were included in the current study. Their information about survival outcome was collected. The primary end point was relapse-free survival (RFS), and the secondary end point was overall survival (OS). RESULTS: For the pathologic stage (pStage 2) patients treated with CAPOX, the 3-year RFS rate was 87.8% and the 3-year OS rate was 92.7%. For the pStage 3 patients treated with SOX and CAPOX, the 3-year RFS rates were respectively 70.9% and 67.8% (hazard ratio [HR], 0.93; 95% confidence interval [CI], 0.50-1.72), whereas the 3-year OS rates were respectively 75.7% and 79.3% (HR, 1.10; 95% CI, 0.54-2.26). Subgroup analysis showed significant interactions between the treatment (SOX vs. CAPOX) and both sex (male vs. female; P = 0.024) and histologic type (diffuse vs. other, P = 0.069). CONCLUSIONS: This exploratory analysis demonstrated that SOX and CAPOX are suggested to have similar efficacy for pStage 3 GC patients after D2 gastrectomy. Differences in the treatment effect according to sex and histologic type warrant further evaluation.

Single-arm confirmatory trial of laparoscopy-assisted total or proximal gastrectomy with nodal dissection for clinical stage I gastric cancer: Japan Clinical Oncology Group study JCOG1401.

BACKGROUNDS: Laparoscopy-assisted distal gastrectomy (LADG) for gastric cancer is safe and feasible. In contrast, no prospective study evaluating the safety and efficacy of laparoscopy-assisted total gastrectomy (LATG) or laparoscopy-assisted proximal gastrectomy (LAPG) has been completed. We conducted a single-arm confirmatory trial to evaluate the safety of LATG/LAPG for clinical stage I (T1N0/T1N1/T2N0) proximal gastric cancer. METHODS: The extent of lymphadenectomy was selected based on the Japanese Gastric Cancer Treatment Guidelines. The mini-laparotomy incision was required to be ≤ 6 cm. The primary endpoint was the proportion of grade 2-4 (CTCAE ver. 4.0) esophagojejunal anastomotic leakage. The planned sample size was 245 considering a threshold of 8% and one-sided alpha of 2.5%. RESULTS: Between April 2015 and February 2017, 244 eligible patients were enrolled. LATG/LAPG was performed in 195/49. The proportion of conversions was 1.7%. Clinical T1N0/T1N1/T2N0 was 212/9/23. The extents of lymphadenectomy were as follows: D1+: 229; D2: 15. The median operation time was 309 min (IQR 265-353). The median blood loss was 30 ml (IQR 10-86). Grade 2-4 esophagojejunal anastomotic leakage was 2.5% (6/244; 95% CI 0.9-5.3). The overall proportion of in-hospital grade 3-4 adverse events was 29% (71/244). The proportions of intraabdominal abscess and pancreatic fistula were 3.7% and 2.0%, respectively. There were no treatment-related deaths. CONCLUSIONS: This trial confirmed the safety of LATG/LAPG. After the non-inferiority of LADG is confirmed in our phase III trial (JCOG0912), LATG/LAPG is expected to be established as one of the standard treatments for clinical stage I gastric cancer.

Safety and Feasibility of Linear Stapling Device with Bioabsorbable Polyglycolic Acid Sheet for Duodenal Closure in Gastric Cancer Surgery: A Multi-institutional Phase II Study.

BACKGROUND: Duodenal stump fistula (DSF) after gastrectomy is of low frequency but a critical complication in gastric cancer surgery. Manual oversewing for reinforcement of the duodenal stump is not applicable when free longitudinal margin is short and has technical difficulties in laparoscopic surgery. This trial evaluated the safety and feasibility of using a linear stapler with bioabsorbable polyglycolic acid (PGA) sheet for duodenal stump closure and reinforcement in gastric cancer surgery. METHODS: This multi-institutional, prospective phase II trial included gastric cancer patients who were scheduled to undergo distal or total gastrectomy with R-Y reconstruction. In all cases, duodenum was transected using a linear stapler with PGA sheet. The primary endpoint was the incidence of postoperative DSF. Sample size was set at 100 patients considering an expected value of 3% and threshold value of 8% with one-sided testing at a 10% significance level. RESULTS: Between June 2014 and June 2015, a total of 100 patients were registered in this trial. Postoperative DSF was observed in two cases (2.0%, 90% CI 0.4-6.2%) which was developed on postoperative days 13 and 20. Intraoperative bleeding at the duodenal stump staple line was observed in one case but was easily controlled without additional suturing. Postoperative bleeding was not observed in any of the cases. CONCLUSION: This study suggested that the use of PGA sheet as a reinforcement material for closure of the duodenal stump during gastrectomy for gastric cancer is both safe and feasible. Trial registration number UMIN 000014398.

Prognostic predictions based on pathological findings of peritoneal dissemination in patients with stage IV colorectal cancer without residual disease (R0 status).

PURPOSE: This study aimed to clarify the prognosis of patients after resection of stage IV colorectal cancer and synchronous peritoneal metastasis (no residual disease: R0 status) based on histopathologic findings. METHODS: The subjects of this study were 26 patients who underwent radical resection of synchronous peritoneal metastases of stage IV colorectal cancer. Only patients with one synchronous peritoneal metastasis were included in this study. The peritoneal lesions were initially classified into two categories based on the presence or absence of adenocarcinoma on their surface: RM-negative or RM-positive. The lesions were subsequently classified as being of massive or diffuse type and of small (< 6 mm) or large (≥ 6 mm) type according to the maximum metastatic tumor dimension. RESULTS: Multivariate analysis revealed that massive type metastatic tumors were associated with a better disease-free survival (DFS; p = 0.047) and overall survival (OS; p = 0.033), than diffuse type tumors. CONCLUSION: A detailed stratification of pathological findings could contribute remarkably to prognostic predictions for patients with synchronous peritoneal metastases.

Nutritional Recovery after Open and Laparoscopic Distal Gastrectomy for Early Gastric Cancer: A Prospective Multicenter Comparative Trial (CCOG1204).

BACKGROUND: Little information from prospective clinical trials is available on the influences of surgical approaches on postoperative body compositions and nutritional status. We designed a prospective non-randomized trial to compare postoperative chronological changes in body composition and nutritional status between laparoscopic and open distal gastrectomy for stage I gastric cancer (GC). METHODS: Body compositions and nutritional indicators in blood tests were measured at the baseline and at the 1st, 3rd, 6th, and 12th postoperative months (POM). The primary end point was the decrease relative to the baseline in the body muscle mass at POM 6. RESULTS: Ninety-six patients for the laparoscopic group and 52 for the open group were eligible for data analysis. No significant differences were found in any baseline demographics, body compositions, and nutritional indicators between the groups. The changes of body muscle mass at POM 6 were similar in both groups. Overall, no significant differences between the groups were observed in any of the body composition and nutritional indicators during the first year after surgery. CONCLUSIONS: Postoperative body compositions and nutritional status were not affected by surgical approaches during the first 12 months after surgery in patients who underwent distal gastrectomy for stage I GC.

A case of local recurrence of T1 rectal cancer 10 years after transanal excision.

We report a case of a patient with T1 rectal cancer, which recurred locally after 10 years from the primary operation. A 78-year-old woman was diagnosed with rectal cancer. Transanal excision (TAE) was performed in December 2006. The pathological findings revealed stage I rectal cancer [tub2>muc, pSM (2,510 µm), ly0, v0, pHM0, pVM0]. Because she did not opt for additional treatment, she received follow-up examination. After approximately 10 years from the primary operation, she presented to her physician, complaining of melena, and she was referred to our hospital again in November 2016. She was diagnosed with recurrent rectal cancer. Laparoscopic abdominoperineal resection was performed in December 2016. Pathological findings revealed stage IIIB rectal cancer (tub2>muc, pA, pN1). The reported postoperative local recurrence rate for T1 rectal cancer after TAE is high, but local recurrence after years from the primary operation is rare. In high-risk cases, local recurrence may be observed even after 10 years from the primary operation. Long-term and close postoperative follow-up is important to detect local recurrence early.

Incidence and treatment of metachronous gastric cancer after proximal gastrectomy.

BACKGROUND AND PURPOSE: Proximal gastrectomy (PG) is a widely accepted function-preserving surgical procedure; however, the incidence and treatment of metachronous gastric cancer (MGC) after PG have been the subject of a number of reports. METHODS: We collected data from 1576 consecutive patients who underwent gastrectomy for gastric cancer between January, 2003 and December, 2010, and analyzed the outcomes of 671 patients treated with PG or distal gastrectomy (DG) for cT1N0 disease. We also discuss the treatments for MGC. RESULTS: MGC was diagnosed within a median follow-up of 52.8 months after PG and DG in six (6.6%) and nine (1.8%) patients, respectively. The cumulative prevalence of MGC after PG was significantly higher than that after DG; P = 0.005. Univariate and multivariate analysis revealed male sex and PG as significant risk factors for MGC (P = 0.014 and P = 0.026, respectively). Five of the six patients who underwent PG were treated by endoscopic submucosal dissection. CONCLUSIONS: The incidence of MGC after PG was significantly higher than that after DG. However, most of the MGCs that developed after PG could be treated by endoscopic submucosal dissection.

[The Case of a Patient with Gastric Cancer Who Showed No Neutropenia Only When Using the Generic S-1 Adjuvant Chemotherapy Formulation].

We report the case of a 72-year-old female who underwent laparoscopic total gastrectomy for gastric cancer. The pathological diagnosis was pT3, N1, M0, pStage II B. She received adjuvant chemotherapy with the TS-1®combination OD tablet, beginning 48 days after gastrectomy. The first course was stopped at day 7 because of neutropenia. The dose was decreased, a second course was started, and the patient completed her second course without neutropenia. After completion of the second course, we discovered that she had taken generic drugs(NKS-1®combination OD tablet)during the second course. She was enrolled in a clinical trial in which the administration of generic drugs was not permitted, as per the protocol. Beginning with the third course, we once again treated her with TS-1, and we observed a return of neutropenia in every subsequent course. We decreased the dose of TS-1 and changed the administration schedule each time. She exhibited no neutropenia only when using the generic S-1 formulation. It is possible that the anti-tumor effect of the generic S-1 formulation, and its associated adverse events, are not identical to the innovator formulation.

Short-term surgical outcomes from a phase III study of laparoscopy-assisted versus open distal gastrectomy with nodal dissection for clinical stage IA/IB gastric cancer: Japan Clinical Oncology Group Study JCOG0912.

BACKGROUNDS: No confirmatory randomized controlled trials (RCTs) have evaluated the efficacy of laparoscopy-assisted distal gastrectomy (LADG) compared with open distal gastrectomy (ODG). We performed an RCT to confirm that LADG is not inferior to ODG in efficacy. METHODS: We conducted a multi-institutional RCT. Eligibility criteria included histologically proven gastric adenocarcinoma in the middle or lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to ODG or LADG. This study is now in the follow-up stage. The primary endpoint is relapse-free survival (RFS) and the primary analysis is planned in 2018. Here, we compared the surgical outcomes of the two groups. This trial was registered at the UMIN Clinical Trials Registry as UMIN000003319. RESULTS: Between March 2010 and November 2013, 921 patients (LADG 462, ODG 459) were enrolled from 33 institutions. Operative time was longer in LADG than in ODG (median 278 vs. 194 min, p < 0.001), while blood loss was smaller (median 38 vs. 115 ml, p < 0.001). There was no difference in the overall proportion with in-hospital grade 3-4 surgical complications (3.3 %: LADG, 3.7 %: ODG). The proportion of patients with elevated serum AST/ALT was higher in LADG than in ODG (16.4 vs. 5.3 %, p < 0.001). There was no operation-related death in either arm. CONCLUSIONS: This trial confirmed that LADG was as safe as ODG in terms of adverse events and short-term clinical outcomes. LADG may be an alternative procedure in clinical IA/IB gastric cancer if the noninferiority of LADG in terms of RFS is confirmed.

A case of metachronous left ovarian metastasis 8 years after surgery for cecal cancer and right ovarian metastasis: Report of a case.

Metachronous ovarian metastasis of colorectal adenocarcinoma is mostly identified within 3 years. Here we present a case of a 64-year-old woman with cecal cancer who underwent right oophorectomy for ovarian metastasis. Imaging was performed because of abdominal bloating; it detected a swollen right ovary with ascites. On laparotomy, a right ovarian tumor and cecal cancer were identified. After right oophorectomy, a diagnosis of unilateral ovarian metastasis from colon cancer was made. One month later, right hemicolectomy was performed. Eight years after initial surgery, the patient presented with vaginal bleeding. A computed tomography (CT) scan revealed a pelvic mass approximately 10 cm in diameter, but no mass was evident on a CT image taken 6 months before. The patient was diagnosed with left ovarian metastasis from colon cancer. A third laparotomy revealed a left ovarian tumor, but there was no evidence of other metastases or peritoneal dissemination. Left oophorectomy was performed. Oophorectomy is considered to be associated with a survival benefit in ovarian metastasis without other extensive metastasis. However, ovarian metastasis is often bilateral. Although complete resection was achieved in the present case, the findings support performing prophylactic bilateral oophorectomy if metastasis is identified in a unilateral ovary.