ComVi Stent Versus Uncovered Self-Expandable Metal Stent (SEMS) for Biliary SEMS Occlusion

Inclusion Criteria:

• Patients with SEMS occlusion, which was inserted either endoscopically or percutaneously, for the relief of malignant nonhilar biliary obstruction
• Patients in whom the above SEMS had been inserted for no less than 7 days

• Patients with one of the following:

  1. cholangitis (as defined by fever, tenderness in the right upper quadrant or epigastrium, and/or a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion)
  2. a ≥ twofold increase in the serum bilirubin level above the baseline after initial SEMS insertion
• Patients in whom the cause of initial ERBD occlusion was identified, such as tumor overgrowth, ingrowth, and/or sludge
• Age ≥ 20 years

Exclusion Criteria:

• Unable to give informed consent
• Patients with sepsis and/or shock not responding to medical treatment or Eastern Cooperative Oncology Group (ECOG) Performance Status 4
• Patients with estimated survival < 4 weeks
• Patients who had undergone curative or palliative surgical intervention
• Hilar or perihilar biliary obstruction
• Patients who had undergone endoscopic nasobiliary drainage,plastic stent insertion, or percutaneous transhepatic biliary drainage prior to second SEMS insertion
• Covered SEMS as initial SEMS
• Migration or food impaction as the cause of initial SEMS occlusion