Adverse Event Severity Grading System Applied to Percutaneous Transhepatic Biliary Metal Stenting as A One- or Two-Stage Procedure in Patients with Unresectable Malignant Extrahepatic Bile Duct Obstruction

Abstract

In the defined study period, 39/102 patients with percutaneous biliary interventions received an equally successful metal stent in a one-stage (n= 23) or two-stage (n=16) procedure. The severity of AEs was as follows: one-stage PTBS (9/23 = 39.1%): 1 (n= 1), 2 (n=3), 3 (n=1), and 4 (n=3); and two-stage PTBS (6/16 = 37.5%): 1 (n=5), 2 (n=1), 3 (n=0), and 4 (n=0). The difference in the severity of AEs was significant (p=0.0252), favoring two-stage PTBS. Overall survival in patients with one-stage PTBS (139.8 (SE +/-43.4) days) and two-stage PTBS (403.3 (SE +/-94.6) days) differed as well (p=0.0065). Conclusion:The ASGE AE severity grading system was applied to PTBS for the first time. Two-stage PTBS might be favored over one-stage PTBS in terms of AEs.