Incidence of Hepatobiliary Injury in Patients Undergoing Dai-kenchu-to Administration Following Gastrectomy: A Retrospective Cohort Study Using Japanese Diagnosis Procedure Combination Data.

Dai-kenchu-to is used to prevent and relieve ileus post-gastrectomy; however, it has been reported to cause hepatobiliary injury in 0.3% of patients, and knowledge regarding its risk in this context is limited. In this study, we aimed to evaluate the effect of dai-kenchu-to, a representative traditional Japanese herbal medicine, on the risk of hepatobiliary injury in patients with gastric cancer who underwent gastrectomy, using real-world data from acute care hospitals. The diagnosis procedure combination data of patients admitted with gastric cancer who underwent gastrectomy between April 2008 and May 2019 were analyzed. The collected data included sex, age, comorbid injuries and illnesses at admission, medication records during hospitalization, and tumor node metastasis classifications. The primary outcome, occurrence of hepatobiliary injury, was identified using records of the use of hepatoprotective agents or cholagogues. The odds ratios of dai-kenchu-to for predisposition to hepatobiliary injury after gastrectomy were estimated using multivariate logistic regression analysis. Herein, 33137 gastric cancer patients who underwent gastrectomy were included in the analysis. The incidences of hepatobiliary injury among patients in the dai-kenchu-to-exposed and non-exposed groups were both 5.9%. The multivariate odds ratio of dai-kenchu-to exposure for hepatobiliary injury was 0.97 (95% confidence interval, 0.73-1.29; p = 0.847). In this study, no risk of moderate-to-severe hepatobiliary injury due to the postoperative administration of dai-kenchu-to was noted in patients with gastric cancer who had undergone gastrectomy. These results provide information regarding the safety of dai-kenchu-to use after gastrectomy in patients with gastric cancer.