Multi-center, randomized controlled study fc-SEMS with anchoring plastic stent vs uc-SEMS in malignant biliary obstruction
This study is multi-center, randomized controlled study to compare the stent patency in malignant biliary obstruction. The patency of fully covered self expandable metal stent with external anchoring plastic stent was compared with that of uncovered self expandable metal stent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
108
Extrahepatic malignant biliary obstruction treated with fully covered self-expandable metal stent with an anchoring plastic stent
Extrahepatic malignant biliary obstruction treated with uncovered self-expandable metal stent without an anchoring plastic stent
Seoul National University Hospital
Seoul, South Korea
RECRUITINGRate of patent stent
The number of patient without stent dysfuction divided by total number of patients
Time frame: 1 year
Stent obstruction
Suspected by jaundice (Total bilirubin \> 2 upper normal limit) or radiologic finding of stent occlusion which is confirmed by ERCP
Time frame: 1 year
Stent migration
Radiologic finding of migration through Abdomen X-ray or CT scan
Time frame: 1 year
Re-intervention
Endoscopic retrograde biliary drainage or Percutaneous transhepatic biliary drainage
Time frame: 1 year
Adverse event
acute cholangitis, acute cholecystitis, acute pancreatitis
Time frame: 1 year
Overall survival
Timespan from the diagnosis to the death
Time frame: 1 year
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