798 Background: Non-ampullary duodenal cancer (NPDC) is a rare cancer that occurs in 0.3% of all cancers of the gastrointestinal tract. The first Japanese guidelines for this entity were published in 2021, and resection by pancreatoduodenectomy was weakly recommended as a standard treatment. Although presence of regional lymph node metastasis was identified as a prognostic factor among patients who underwent resection with curative intent, the recommendation concerning the optimal extent of lymphadenectomy based on big data was lacking. Methods: We conducted an observational study of patients who underwent pancreatoduodenectomy for NPDC between 2018 and 2021 in Japan, using the National Clinical Data (NCD) database. The NCD database is web-based, is linked with the board certification systems of several domestic surgical societies and covers >95% of the operations carried out by surgeons at 5,728 institutions in Japan. All cases of pancreatoduodenectomy for NPSC were retrieved from the NCD database after rigorously checking appropriateness of the patient selection, and surgeons in charge of these patients were invited by e-mails to fill in some additional data for this study during a time slot of Oct 2022 ~March 2023. Data thus obtained were the analyzed with particular focus on the incidence of metastases to each lymph node station, stratified by the tumor location in relation to the papilla. In addition, safety of surgery was compared between high-volume (institutions conducting ≥30 major hepatobiliary-pancreatic surgery) and low-volume (<30) hospitals. The study was funded in part by the Japanese Ministry of Health, Labor and Welfare as a project to create guidelines for rare cancers. Results: Data of 881 patients from 600 institutions were obtained for the analysis. Male constituted 68% and the median age was 70 years. The depth of invasion and presence of nodal metastasis were significant prognostic factors. The median number of lymph node retrieval was similar between the high-volume and low-volume hospitals (19: 95%CI 12~27 versus 18: 95% CI 11~25). Distribution of metastatic nodes depended on the location of tumor. Incidence of nodal metastasis exceeded 10% in lymph node station Nos. 5, 6, 7, 8 and 9 in cancers located on the oral side of the papilla. Thus, stomach-conserving pancreatoduodenectomy was considered appropriate only for cancers located distal to the papilla. The incidences of Grade IIIb~IVb complications (4% versus 7.1%), Grade V complications (0.4% versus 1.9%), and mortality within 30 days (0.4% versus 2.6%) were lower in high-volume hospitals. Conclusions: Stomach-preserving pancreatoduodenectomy is recommended only for NDPC located distal to the papilla. Centralization of surgery may be desirable.
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