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Subsequent ERBD After Occlusion of Metal Biliary Stent in Patients With Unresectable Malignant Biliary Obstruction - Comparison of ComVi Stent Versus Uncovered Metal Stents


Phase 4
20 Years
N/A
Open (Enrolling)
Both
Biliary Tract Neoplasms, Jaundice, Obstructive

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Trial Information

Subsequent ERBD After Occlusion of Metal Biliary Stent in Patients With Unresectable Malignant Biliary Obstruction - Comparison of ComVi Stent Versus Uncovered Metal Stents


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Time to stent occlusion

Outcome Time Frame:

Upon SEMS occlusion, patient death, or end of the study period (average 1 year)

Safety Issue:

Yes

Principal Investigator

Ji Kon Ryu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital, Seoul National University College of Medicine

Authority:

Korea: Institutional Review Board

Study ID:

ERBD2SEMS

NCT ID:

NCT01315522

Start Date:

June 2010

Completion Date:

Related Keywords:

  • Biliary Tract Neoplasms
  • Jaundice, Obstructive
  • Stents
  • Endoscopy
  • Cholangiopancreatography
  • Endoscopic Retrograde
  • Biliary Tract Neoplasms
  • Neoplasms
  • Jaundice
  • Jaundice, Obstructive

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