Table 2 Criteria for primary endpoint of stent dysfunction

Meeting one or more of the following criteria:

□ Suspected cholangitis [13]

□ Definite cholangitis [13]

□ 50% increase in bilirubin from the lowest level post index procedure

□ 20% increase in bilirubin from the lowest level post index procedure AND evidence of obstruction on imaging (US/CT/MRI)

AND:

□ Endoscopic or radiological re-intervention confirming stent blockage or migration needing stent cleaning, stent change, and/or additional stent insertion