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Table 3 Secondary endpoints

From: ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction

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