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Table 2 Criteria for primary endpoint of stent dysfunction

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

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