1. Technical success defined as successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization [6,7,8] | |
2. Clinical success defined as 50% decrease in bilirubin < 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion [6] | |
3. Stent patency defined as mean time to stent obstruction or migration (patient will be censored at last-follow-up or death) | |
4. Proportion of patients with interruptions in chemotherapy treatment due to recurrent stent dysfunction | |
5. Early adverse events (within 14 days of index procedure) as defined per the ASGE lexicon for endoscopic adverse events [18], including post-procedural pancreatitis, bleeding, intestinal perforation, and cholangitis | |
6. Delayed adverse events (greater than 14 days of index procedure until last follow-up or death) | |
7. Cost-effectiveness analysis | |
Additional outcomes | |
1. Median number of days in delayed chemotherapy treatment if interrupted | |
2. Procedure time defined as from insertion of the endoscope to endoscope withdrawal1 | |
3. Fluoroscopy time | |
4. Rate of hospitalization and length of stay | |
5. Mortality |