Statistical analysis
SD, cholangitis
CHOLANGITIS
The sample size was calculated based on the primary endpoint of DOF. In patients with mild cholangitis, CSTS was assumed to be non-inferior to MEPM with a noninferiority margin of 5 days. Assuming that the difference between the groups is 7 days (SD, 18), the minimum number of patients required in each group is 29 (α=0.05, power=80%). Considering an expected dropout rate of 10%, a total of 66 patients (33 in each group) with mild cholangitis were required. For patients with severe cholangitis, we assumed that MEPM+IVIG was superior to MEPM. Assuming that the difference between groups is 15 days (SD, 18), the minimum number of patients required in each group would be 24 (α=0.05, power=80%). Considering an expected dropout rate of 10%, a total of 52 patients (26 in each group) with severe cholangitis were required.All analyses were performed on an intention-to-treat basis. Continuous variables are presented as mean (SD) or median (IQR) and compared using the Student’s 