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Table 2 Primary and secondary endpoints

From: Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol

Primary endpoint:
- Rate of recurrent biliary obstruction (RBO) between the two strategies (LAMS with and without coaxial DPS), detected during follow-up.
*RBO is associated with a stent dysfunction (an endpoint of either occlusiona or migrationb). Tokyo criteria
- Clinical recurrence (jaundice, fever, suspicious colangitis, pruritus).
- Recurrence of cholestasis parameters (Any increase in GGT/ALP or bilirubin from its lowest level post-index procedure).
Both WITH evidence of biliary obstruction on imaging (dilation on US/CT/MRI) or endoscopic findings suggesting it c.
Secondary endpoints:
- Technical success defined as successful stents (LAMS, DPS, or either) between the extrahepatic biliary duct and the upper gastrointestinal tract determined by endoscopy, endosonography, or fluoroscopy.
- Clinical success defined as > 50% decrease in bilirubin at 14 days from stent placement. For cholangitis, clinical success is defined as cessation of antibiotics or normalization of levels of blood inflammatory markers within 14 days of stent placement.
- Safety, as defined per the ASGE lexicon/Tokyo criteria for endoscopic AEs and divided into early adverse events (within 14 days of index procedure) and delayed AE (> 14 days).
- Additional outcomes: t-RBO, BRI, procedure time, and survival/mortality rates.
  1. AE adverse event, ALP alkaline phosphatase, ASGE American Society of Gastrointestinal Endoscopy, BRI biliary reintervention, CT computed tomography, ERCP endoscopic retrograde cholangio-pancreatography, EUS endoscopic ultrasound, GGT gamma-glutamyl transferase, RBO recurrent biliary obstruction, US ultrasound, MRI magnetic resonance imaging
  2. aStent occlusion defined as elevation of inflammatory parameters/cholestasis evidence along with biliary dilation on imaging studies or endoscopic findings. Tokyo criteria [20]
  3. bStent migration defined as presence of completely/partially migrated stent at the time of endoscopic reintervention with evident stent dysfunction
  4. cCauses of stent occlusions: tumor ingrowth/overgrowth, biliary sludge, food impaction, hemobilia, kinking of CBD to stent). Tokyo criteria [20]