This retrospective study examined data from 552 patients who were diagnosed with PC between January 2011 and December 2013 at Ehime University Hospital and its affiliated centers (EPOCH Study Group) after excluding patients with unknown viral hepatitis status (hepatitis B surface antigen [HBsAg] and anti-HCV antibodies). We surveyed data on age, sex, the trigger of PC diagnosis, liver-related blood tests [platelet counts, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, and albumin], and UICC stage (7th edition) [16 ]. All data were collected at the time of PC diagnosis (or before PC treatment for patients requiring biliary drainage due to obstructive jaundice). Data regarding patient outcomes (survival, lost to follow-up, and death) were collected as of May 2017.
PC diagnosis was based on tumor markers, abdominal imaging, and/or histological findings, as described elsewhere [3 (link)]. The staging of PC was determined according to the clinical stage, except for stage 0, which was confirmed pathologically [11 (link)]. Since a nationwide survey of PC revealed significant differences in 5-year survival between stage IB (59.7%) and stage IIA (30.2%) [2 (link)], stages 0–IB were defined as early stages in this study, while stages IIA–IV were defined as non-early stages.
In this study, liver biopsy was considered the gold standard for diagnosing CLD. The aspartate aminotransferase-to-platelet ratio index (APRI) was calculated in patients with CLD. However, the final decision on the interval of HCC surveillance is made by individual hepatologists. Abdominal imaging (ultrasound, CT, MRI) and tumor markers analysis (AFP, DCP) were generally performed every three to four months in cirrhosis patients and every six months in non-cirrhosis patients, according to the guideline recommendations [10 (link)].
Data are reported as mean ± standard deviation or number and percentage. Intergroup comparisons were performed using the chi-squared test. Outcomes were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. Differences in survival analyses were determined using the log-rank test. The differences were considered statistically significant at a two-tailed p-value < 0.05. All statistical analyses were performed using JMP software (version 13; SAS Institute, Cary, NC, USA). To ensure the anonymity of patient data, the data were stored in a secure database, and the patients were numerically coded. The study protocol complied with the ethical guidelines of the Declaration of Helsinki and was approved by the ethics committee of Ehime University Graduate School of Medicine (1204066). The requirement for written consent was waived owing to the study’s retrospective nature.
PC diagnosis was based on tumor markers, abdominal imaging, and/or histological findings, as described elsewhere [3 (link)]. The staging of PC was determined according to the clinical stage, except for stage 0, which was confirmed pathologically [11 (link)]. Since a nationwide survey of PC revealed significant differences in 5-year survival between stage IB (59.7%) and stage IIA (30.2%) [2 (link)], stages 0–IB were defined as early stages in this study, while stages IIA–IV were defined as non-early stages.
In this study, liver biopsy was considered the gold standard for diagnosing CLD. The aspartate aminotransferase-to-platelet ratio index (APRI) was calculated in patients with CLD. However, the final decision on the interval of HCC surveillance is made by individual hepatologists. Abdominal imaging (ultrasound, CT, MRI) and tumor markers analysis (AFP, DCP) were generally performed every three to four months in cirrhosis patients and every six months in non-cirrhosis patients, according to the guideline recommendations [10 (link)].
Data are reported as mean ± standard deviation or number and percentage. Intergroup comparisons were performed using the chi-squared test. Outcomes were analyzed using the Kaplan–Meier method and Cox proportional hazards regression. Differences in survival analyses were determined using the log-rank test. The differences were considered statistically significant at a two-tailed p-value < 0.05. All statistical analyses were performed using JMP software (version 13; SAS Institute, Cary, NC, USA). To ensure the anonymity of patient data, the data were stored in a secure database, and the patients were numerically coded. The study protocol complied with the ethical guidelines of the Declaration of Helsinki and was approved by the ethics committee of Ehime University Graduate School of Medicine (1204066). The requirement for written consent was waived owing to the study’s retrospective nature.
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