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 |