Surgically treated gastric cancer in Japan: 2011 annual report of the national clinical database gastric cancer registry.

BACKGROUND: The National Clinical Database (NCD) nationwide registry program of gastric cancer started in 2018. The purpose of this study was to report the treatment results of the NCD registry in the form of treatment results of the real world in Japan. METHODS: Patients' characteristics, tumor features, treatments, and outcomes were collected using a web-based data entry system. We analyzed the initial NCD database for data on surgically treated gastric cancer patients in 2011. RESULTS: A total of 30,257 patients with malignant gastric tumors were enrolled by the NCD registry program from 501 hospitals in all 47 prefectures. Of these, the status of data entry was not approved in 8.8% of the registered data, and follow-up information was missing in 1.2% of the approved cases. Excluding 1777 cases, which were not resected for primary gastric cancer, 25,306 resected cases included 44.4% of stomach surgeries recorded in the NCD. The 5 year survival rate of the resected cases was 71.3% and the operative mortality rate was 0.41%. The stage-specific 5 year survival rates were as follows: 89.6% for stage IA, 83.8% for stage IB, 77.3% for stage IIA, 69.1% for stage IIB, 58.7% for stage IIIA, 44.1% for stage IIIB, 30.1% for stage IIIC, and 13.4% for stage IV. CONCLUSIONS: The NCD gastric cancer registry program demonstrated validity for database construction. The gastric cancer registry is expected to become a nationwide registry with the dissemination of data entry system and method in the NCD.

Determinant Factors on Differences in Survival for Gastric Cancer Between the United States and Japan Using Nationwide Databases.

BACKGROUND: Although the incidence and mortality have decreased, gastric cancer (GC) is still a public health issue globally. An international study reported higher survival in Korea and Japan than other countries, including the United States. We examined the determinant factors of the high survival in Japan compared with the United States. METHODS: We analysed data on 78,648 cases from the nationwide GC registration project, the Japanese Gastric Cancer Association (JGCA), from 2004-2007 and compared them with 16,722 cases from the Surveillance, Epidemiology, and End Results Program (SEER), a United States population-based cancer registry data from 2004-2010. We estimated 5-year relative survival and applied a multivariate excess hazard model to compare the two countries, considering the effect of number of lymph nodes (LNs) examined. RESULTS: Five-year relative survival in Japan was 81.0%, compared with 45.0% in the United States. After controlling for confounding factors, we still observed significantly higher survival in Japan. Among N2 patients, a higher number of LNs examined showed better survival in both countries. Among N3 patients, the relationship between number of LNs examined and differences in survival between the two countries disappeared. CONCLUSION: Although the wide differences in GC survival between Japan and United States can be largely explained by differences in the stage at diagnosis, the number of LNs examined may also help to explain the gaps between two countries, which is related to stage migration.

Preoperative skill evaluation in transabdominal preperitoneal (TAPP) inguinal hernia repair using a three-dimensional printed TAPP repair simulator.

BACKGROUND: Although transabdominal preperitoneal laparoscopic inguinal hernia repair (TAPP LIHR) is becoming increasingly more critical in the management of hernias, it has a long learning curve. The learning curve is often measured by a shortened operative time without mention of the quality of the procedure. This study was performed to evaluate the efficacy of a three-dimensional printed TAPP LIHR simulator to evaluate the surgeon's preoperative skill before entering the operative theater. METHODS: Fifteen surgeons in our institution were enrolled in this study. They performed simulation TAPP LIHR while being video recorded. The TAPP LIHR simulator allows for the performance of all procedures required in TAPP LIHR. All participants were classified according to several background factors: postgraduate years (PGYs) (1-5, 6-10, or > 10), number of TAPP LIHR procedures performed (< 10, 11-49, or > 50), and number of laparoscopic surgeries performed (≤ 100 or > 100). The correlation among PGYs, the number of TAPP repairs performed, and the checklist score was evaluated. RESULTS: The mean total score and time required to perform TAPP LIHR were significantly different among the three TAPP LIHR experience groups (< 10, 11-49, and > 50 procedures; P < 0.05). The checklist score and time required to perform TAPP LIHR were strongly correlated with the number of TAPP LIHR procedures performed (r = 0.74 and r = 0.69, respectively). However, the checklist score showed a weak correlation with PGY (r = 0.52). CONCLUSIONS: Preoperative skill evaluation using a TAPP LIHR simulator and TAPP repair checklist supports the distinction between novices and experts. Both education systems are a valuable and affordable tool for evaluation and training of TAPP LIHR.

What are the important prognostic factors in gastric cancer with positive duodenal margins? A multi-institutional analysis.

PURPOSE: Positive margins are reported in from 4.8 to 9.5% of all gastric cancer surgeries and they have a negative impact on the overall survival. Few cases with positive duodenal margins have been included in previous studies regarding the prognosis. METHODS: This multi-institutional retrospective study included 115 gastric cancer patients with positive duodenal margins following gastrectomy between January 2002 and December 2017. The association between clinicopathological factors and the overall survival was evaluated by univariate and multivariate analyses. RESULTS: The three-year overall survival was 22% and the median survival was 13 months. A multivariate analysis found that distant metastasis, no postoperative chemotherapy, and non-Type 4 disease were significantly associated with a poor survival. Patients without distant metastasis who received postoperative chemotherapy had a 3-year overall survival of 56% and a median survival of 44 months. CONCLUSION: The patients who underwent post-operative chemotherapy showed a significantly better OS compared with those who did not undergo post-operative chemotherapy, regardless of the existence of distant metastasis. Postoperative chemotherapy may, therefore, improve the prognosis of surgically treated gastric cancer patients with positive duodenal margins.

Surgical outcomes of elderly patients with Stage I gastric cancer from the nationwide registry of the Japanese Gastric Cancer Association.

BACKGROUND: The proportion of elderly patients undergoing surgery for gastric cancer is increasing. However, limited number of therapeutic outcomes in the elderly has been reported. Here we examined the surgical results based on a nationwide survey of elderly patients who underwent surgery for Stage I gastric cancer. METHODS: Data from 68,353 Stage I patients who underwent gastrectomy between 2001 and 2007 were retrospectively collected. The accumulated data were reviewed and analyzed by the Japanese Gastric Cancer Association registration committee. We first classified the patients as those aged ≤ 74 years and ≥ 75 years. We further classified those patients aged ≥ 75 years into groups by 5-year increments to examine their short- and long-term postoperative outcomes. RESULTS: Patients aged ≥ 75 years accounted for 46.5%. The 30-day mortality rate was < 0.7% for any age group, but for those aged ≥ 75 years, the 60-day and 90-day mortality rates were 0.9-2.3% and 1.2-5.1%, respectively. An examination of long-term survival indicated that, as the class of age increased, the 5-year overall survival (OS) was 47.0-93.1% and disease-specific survival (DSS) was 91.4-98.2%, respectively. Although high DSS rates of ≥ 90% were found for all age groups, OS only accounted for ≤ 82% of patients aged ≥ 75 years. CONCLUSION: Among elderly patients with Stage I gastric cancer, deaths due to other diseases were frequently observed in the long term. Thus, for elderly patients, it may be appropriate to reconsider the treatment strategy with respect to the balance between the invasiveness of the treatment and the prognosis.

Optimal extent of lymph node dissection for remnant advanced gastric carcinoma after distal gastrectomy: a retrospective analysis of more than 3000 patients from the nationwide registry of the Japanese Gastric Cancer Association.

BACKGROUND: No guidelines are available for defining the extent of lymph node (LN) dissection in patients with remnant gastric carcinoma (RGC). Hence, this retrospective study aimed to determine the optimal extent of LN dissection in patients with RGC. METHODS: We retrospectively evaluated the therapeutic outcomes of node dissection for RGC from a nationwide registry. When the metastatic rate or 5-year survival rate exceeded 10%, dissection was recommended. We calculated the dissection index by multiplying the incidence of metastasis at that nodal station by the 5-year survival rate of patients with metastasis at the station. A dissection index of > 1.0 was considered significant. RESULTS: We included 1133 patients with RGC (T2-T4 tumor) who had undergone distal gastrectomy as the primary surgery for the evaluation of the survival benefit of nodal dissection. Any regional node station was considered significant. When the primary surgery was for malignant disease, the index was high for Nos. 3 (10.2), 7 (9.5), 1 (7.1), and 9 (8.0) nodes. For nodes at the splenic hilum, the index value was 4.4, which was higher than that for the perigastric nodes (Nos. 4sa and 4sb). The index for No. 10 nodes was the highest (10.5) when tumors involved a greater curvature. CONCLUSIONS: The therapeutic strategy for RGC remains the same, regardless of the histology of the primary disease during the initial surgery. Total gastrectomy and dissection of the perigastric LNs (Nos. 1-4), suprapancreatic LNs (Nos. 7-9 and 11), and LNs at the splenic hilum (No. 10) are justified.

Five-year survival analysis of surgically resected gastric cancer cases in Japan: a retrospective analysis of more than 100,000 patients from the nationwide registry of the Japanese Gastric Cancer Association (2001-2007).

BACKGROUND: The aim of this retrospective study was to investigate the tumor characteristics, surgical details, and survival distribution of surgically resected cases of gastric cancer from the nationwide registry of the Japanese Gastric Cancer Association. METHODS: Data from 118,367 patients with primary gastric carcinoma who underwent resection between 2001 and 2007 were included in the survival analyses. The 5-year survival rates were calculated for various subsets of prognostic factors. RESULTS: The median age of the patients was 67 years. The proportions of patients with pathological stage (Japanese Gastric Cancer Association) IA, IB, II, IIIA, IIIB, and IV disease were 44.0%, 14.7%, 11.7%, 9.5%, 5.0%, and 12.4% respectively. The death rate within 30 days of operation was 0.5%. The 5-year overall survival rate in the 118,367 patients who were treated by resection was 71.1%. The 5-year overall survival rates of patients with pathological stage IA, IB, II, IIIA, IIIB, and IV disease were 91.5%, 83.6%, 70.6%, 53.6%, 34.8%, and 16.4% respectively. The 5-year disease-specific survival rates in the patients with pT1 (mucosa) disease after D1+ dissection of lymph node station no. 7 (D1 + α), D1+ dissection of lymph node station nos. 7, 8, and 9 (D1+ ß), and D2 lymphadenectomy were 99.4%, 99.6%, and 99.1% respectively. The 5-year disease-specific survival rates in the patients with pT1 (submucosa) disease after D1 + α, D1 + ß, and D2 lymphadenectomy were 97.3%, 98.1%, and 96.9% respectively. CONCLUSION: Detailed analyses of the data from more than 100,000 patients show the recent trends of the outcomes of gastric cancer treatment in Japan and provide baseline information for use by medical communities around world.

Gastric cancer treated by endoscopic submucosal dissection or endoscopic mucosal resection in Japan from 2004 through 2006: JGCA nationwide registry conducted in 2013.

BACKGROUND: The Japanese Gastric Cancer Association (JGCA) initiated a new nationwide gastric cancer registry in 2008 and reported the treatment outcomes of patients with primary gastric cancer who underwent surgical therapy in 2001 and 2003. However, the outcomes of endoscopic therapy have not been reported yet. METHODS: The JGCA conducted a retrospective nationwide registry in 2013 to investigate the short-term and long-term outcomes of endoscopic mucosal resection or endoscopic submucosal dissection in patients with gastric cancer treated from January 2004 through December 2006. This registry used a computerized database with terminology in accordance with the JGCA classification (13th and 14th editions) and the Japanese Gastric Cancer Treatment Guidelines from 2010. RESULTS: Accurate data on 12,647 patients were collected from 126 participating hospitals and analyzed. The treatment procedure was endoscopic submucosal dissection in 81% of the patients and endoscopic mucosal resection in 19%. En bloc and R0 resections were achieved in 89% and 79% of the patients respectively. The total proportion of patients who underwent curative resection was 69.2%; 43.8% of patients underwent curative resection for absolute indication lesions, and 25.4% underwent curative resection for expanded indication lesions. Emergency surgery was performed to treat bleeding or perforation in very few patients (0.3% and 0.4% respectively). The 5-year follow-up rate after endoscopic resection was 70%. The 5-year overall survival rate was 91.6% in patients with absolute indications and 90.3% in patients with expanded indications after curative resection and 86.5% in patients who underwent noncurative resection. The 5-year disease-specific survival rates were 99.9%, 99.7%, and 98.7% in patients with absolute indications who underwent curative resection, patients with expanded indications who underwent curative resection, and patients who underwent noncurative resection respectively. CONCLUSION: Endoscopic resection of gastric cancer resulted in favorable short-term and long-term outcomes nationwide in Japan. Further efforts to increase the follow-up rate are needed.

Validation of newly developed physical laparoscopy simulator in transabdominal preperitoneal (TAPP) inguinal hernia repair.

BACKGROUND: A realistic simulator for transabdominal preperitoneal (TAPP) inguinal hernia repair would enhance surgeons' training experience before they enter the operating theater. The purpose of this study was to create a novel physical simulator for TAPP inguinal hernia repair and obtain surgeons' opinions regarding its efficacy. METHODS: Our novel TAPP inguinal hernia repair simulator consists of a physical laparoscopy simulator and a handmade organ replica model. The physical laparoscopy simulator was created by three-dimensional (3D) printing technology, and it represents the trunk of the human body and the bendability of the abdominal wall under pneumoperitoneal pressure. The organ replica model was manually created by assembling materials. The TAPP inguinal hernia repair simulator allows for the performance of all procedures required in TAPP inguinal hernia repair. Fifteen general surgeons performed TAPP inguinal hernia repair using our simulator. Their opinions were scored on a 5-point Likert scale. RESULTS: All participants strongly agreed that the 3D-printed physical simulator and organ replica model were highly useful for TAPP inguinal hernia repair training (median, 5 points) and TAPP inguinal hernia repair education (median, 5 points). They felt that the simulator would be effective for TAPP inguinal hernia repair training before entering the operating theater. All surgeons considered that this simulator should be introduced in the residency curriculum. CONCLUSIONS: We successfully created a physical simulator for TAPP inguinal hernia repair training using 3D printing technology and a handmade organ replica model created with inexpensive, readily accessible materials. Preoperative TAPP inguinal hernia repair training using this simulator and organ replica model may be of benefit in the training of all surgeons. All general surgeons involved in the present study felt that this simulator and organ replica model should be used in their residency curriculum.

Development and validation of a high-quality simulator with exchangeable peritoneum for transabdominal preperitoneal laparoscopic inguinal hernia repair.

INTRODUCTION: Practical simulation training with proper haptic feedback and the fragility of the human body is required to overcome the long learning curve associated with laparoscopic inguinal hernia repair (LIHR). However, few hernia models accurately reflect the texture and fragility of the human body. Therefore, in this study, we developed a novel model for transabdominal preperitoneal (TAPP) LIHR training and evaluated its validity. METHODS: We developed a high-quality mock peritoneum with a hydrated polyvinyl alcohol layer and a unique two-way crossing cellulose fiber layer. To complete the simulation, the peritoneum was adhered to a urethane foam inguinal base with surgical landmarks. Participants could perform all the procedures required for the TAPP LIHR. Twenty-four surgeons performed TAPP LIHR simulation using a novel simulator. Their opinions were rated on a 5-point Likert scale. Additionally, 6 surgical residents and 10 surgical experts performed the procedure. Their performance was evaluated using the TAPP checklist score and procedure time. RESULTS: Most participants strongly agreed that the TAPP LIHR simulator with an exchangeable peritoneum model was useful. The participants agreed on the model fidelity for tactile sensation, forceps handling, and humanlike anatomy. In comparisons between surgical residents and experts, the experts had significantly higher scores (10.6 vs. 17.2, p < 0.05) and shorter procedure times (92.3 vs. 55.9 min; p < .05) than did surgical residents. CONCLUSIONS: We developed a high-quality exchangeable peritoneal model that mimics the human peritoneum's texture and fragility. This model enhances laparoscopic simulation training, potentially shortening TAPP LIHR learning curves.

Gastric cancer treated in 2002 in Japan: 2009 annual report of the JGCA nationwide registry.

BACKGROUND: The Japanese Gastric Cancer Association (JGCA) started a new nationwide gastric cancer registration in 2008. METHODS: From 208 participating hospitals, 53 items including surgical procedures, pathological diagnosis, and survival outcomes of 13,626 patients with primary gastric cancer treated in 2002 were collected retrospectively. Data were entered into the JGCA database according to the JGCA classification (13th edition) and UICC TNM classification (5th edition) using an electronic data collecting system. Finally, data of 13,002 patients who underwent laparotomy were analyzed. RESULTS: The 5-year follow-up rate was 83.3 %. The direct death rate was 0.48 %. UICC 5-year survival rates (5YEARSs)/JGCA 5YEARSs were 92.2 %/92.3 % for stage IA, 85.3 %/84.7 % for stage IB, 72.1 %/70.0 % for stage II, 52.8 %/46.8 % for stage IIIA, 31.0 %/28.8 % for stage IIIB, and 14.9 %/15.3 % for stage IV, respectively. The proportion of patients more than 80 years old was 7.8 %, and their 5YEARS was 51.6 %. Postoperative outcome of the patients with primary gastric carcinoma in Japan have apparently improved in advanced cases and among the aged population when compared with the archival data. Further efforts to improve the follow-up rate are needed. CONCLUSIONS: Postoperative outcome of the patients with primary gastric carcinoma in Japan have apparently improved in advanced cases and among the aged population when compared with the archival data. Further efforts to improve the follow-up rate are needed.

Reevaluation of serum p53 antibody as a tumor marker in colorectal cancer patients.

PURPOSE: We reevaluated the serum p53 antibody (S-p53Ab) ELISA kit, which was approved as a tumor marker of colon cancer in the Japanese Health Insurance System in 2007. METHODS: S-p53Ab was measured as a tumor marker in 154 colorectal cancer patients, and the results were categorized by clinical and pathological variables. We then compared the positive frequency of S-p53Ab, carcinoembryonic antigen (CEA), and carbohydrate 19-9 (CA19-9). RESULTS: S-p53Ab was positive in 33.1% of the colorectal cancer patients. The positive rate was significantly higher in patients with lymph nodes metastasis (P = 0.025) and lymphatic invasion (P = 0.023). In patients with stage I colorectal cancer, the positive rate of S-p53Ab (23.7%) was significantly higher than that of CEA (5.3%) or CA19-9 (7.9%). CONCLUSION: The approved kit for S-p53Ab testing was found to be an effective tumor marker of colorectal cancer. The positive rate of S-p53Ab was significantly higher in patients with cancer involvement of the lymphoid tissues. The positive rate of S-p53Ab was higher than that of CEA and CA19-9 in patients with stage I colorectal cancer, suggesting that the S-p53Ab is a useful tumor marker for patients with early-stage disease.

Gastric cancer treatment in Japan: 2008 annual report of the JGCA nationwide registry.

The Japanese Gastric Cancer Association (JGCA) started a new nationwide gastric cancer registry in 2008. Approximately 50 data items, including surgical procedures, pathological diagnoses, and survival outcomes, for 12004 patients with primary gastric cancer treated in 2001 were collected retrospectively from 187 participating hospitals. Data were entered into the JGCA database according to the JGCA Classification of gastric carcinoma, 13th edition and the International Union Against Cancer (UICC) TNM Classification of malignant tumors, 5th edition by using an electronic data collecting system. Finally, data of 11261 patients with gastric resection were analyzed. The 5-year follow-up rate was 83.5%. The direct death rate was 0.6%. TNM 5-year survival rates (5YSRs)/JGCA 5YSRs were 91.8/91.9% for stage IA, 84.6/85.1% for stage IB, 70.5/73.1% for stage II, 46.6/51.0% for stage IIIA, 29.9/33.4% for stage IIIB, and 16.6/15.8% for stage IV. The proportion of patients more than 80 years old was 7.0%, and their 5YSR was 48.7%. Compared to the JGCA archived data, though the follow-up rate needs to be improved, these data suggest that the postoperative results of patients with primary gastric carcinoma have improved in those with advanced disease and in the aged population in Japan.

Comparison of olanexidine versus povidone-iodine for preventing surgical site infection in gastrointestinal surgery: study protocol for a multicentre, single-blind, randomised controlled clinical trial.

INTRODUCTION: The prevalence of surgical site infection (SSI) remains higher in gastrointestinal surgery than in other surgeries. Although several guidelines have indicated the efficacy of chlorhexidine and povidone-iodine in reducing the SSI rate, the optimal recommendation has still not been established. Therefore, it is necessary to determine the more effective antiseptic for surgical site preparation. Olanexidine (1.5% olanedine, Otsuka Pharmaceutical Factory, Tokushima, Japan), which is a new antiseptic in Japan, has antimicrobial activity against a wide range of bacteria, including Gram-positive and Gram-negative bacteria. Our study will contribute to determining a new antiseptic for use in gastrointestinal and other surgeries. METHODS AND ANALYSIS: We propose a multicentre, randomised controlled clinical trial for comparing two treatments, that is, 1.5% olanexidine or 10% povidone-iodine, for surgical skin preparation to prevent SSI in clean-contaminated gastrointestinal surgeries with surgical wounds. Patients aged ≥20 years at the time of consent will be included. The primary outcome measure is the 30-day postoperative SSI rate. For the primary analysis, which is aimed at comparing the treatment effects, the adjusted risk ratio and its 95% CI will be estimated using the Mantel-Haenszel method. ETHICS AND DISSEMINATION: The protocol was first approved by the Institutional Review Board of Keio University School of Medicine, followed by the institutional review board of each participating site. Participant recruitment began in June 2018. The final results will be published in international peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: UMIN 000031560; Pre-results.

Laparoscopic orchidopexy with transabdominal preperitoneal hernia repair in an adult.

We report an adult who underwent laparoscopic orchidopexy and transabdominal preperitoneal hernia repair. The patient was a 53-year-old man who was referred to our hospital for a bulge and pain in his left inguinal area. An abdominal CT scan revealed that the greater omentum was incarcerated in a left inguinal hernia. The patient underwent emergency laparoscopic surgery immediately. After reduction, he was diagnosed with bilateral cryptorchidism and inguinal hernia. After adequate mobilization, pneumoperitoneum was discontinued, and orchidopexy was performed with the Lichtenstein tension-free hernioplasty. One month later, the patient underwent elective laparoscopic orchidopexy with transabdominal preperitoneal hernia repair on his right side. The patient's postoperative course has been uneventful, with no evidence of hernia recurrence to date. This procedure is safe and may be an option for adult patients who desire testis preservation. This may be the first report of laparoscopic hernia repair with orchidopexy.

Validation of a Japanese Version of the Decision Regret Scale.

BACKGROUND AND PURPOSE: In Japanese health care, no current index measures patient satisfaction with decision making during the treatment process. Our research aimed to test a Japanese version of the Decision Regret Scale (DRS) for this purpose. METHODS: We distributed a Japanese version of the DRS twice, 3 weeks apart, to 80 postoperative patients younger than the age of 85 years with inguinal hernias, cholelithiasis, cholecystitis, and gallbladder polyps. RESULTS: The reliability (α = .85) and validity of the Japanese version of the DRS was demonstrated among postoperative patients. CONCLUSION: The Japanese version of the DRS will have significant implications for clinicians in improving their shared decision making with patients.

Gastric volvulus with a large bochdalek hernia in an adult successfully treated with emergency endoscopic reduction followed by elective laparoscopic mesh repair: A case study.

We report a case of gastric volvulus with a large Bochdalek hernia successfully treated with emergency endoscopic reduction followed by elective laparoscopic mesh repair. The patient was a 71-year-old woman with no history of trauma. She was referred to our hospital because of nausea and vomiting after eating. Thoracic and abdominal CT showed gastric volvulus and a large Bochdalek hernia. The patient underwent emergency endoscopic reduction and elective laparoscopic surgery. The defect (10 × 12 cm) was reinforced with a Dual Mesh (expanded polytetrafluoroethylene) and fixed to the diaphragm with nonabsorbable sutures. The postoperative course was uneventful, and no complications or recurrence was found at the 2-year follow-up. The endoscopic reduction and elective laparoscopic procedure was performed successfully and resulted in significant clinical improvement in this case.