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Which is better as a second-line stent between covered metal stent and uncovered metal stent for the palliation of unresectable malignant biliary obstruction?

Not Applicable
Completed
Conditions
Diseases of the digestive system
Registration Number
KCT0001321
Lead Sponsor
Seoul National University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
60
Inclusion Criteria

?Patients with advanced malignant distal bile duct obstrucion underwent biliary stent insertion by endoscopic nasobiliary drainage or percutaneous transhepatic biliary drainage
?No less 7 days since stent insertion procedure.
?One of the followings since stent insertion procedure.
(a) Cholangitis
(b) Increase of bilirubin level more than 2 times since the time of stent insertion.
?Confirmed obstruction cause such as tumor overgrowth, ingrowth, or sludge impaction during secondary stent insertion through endoscopic retrograde cholangiopancreatography

Exclusion Criteria

?Informed consent not attainable
?Septic shock at time of endoscopic retrograde cholangiopancreatography, or Eastern Cooperative Oncology Group perfomance status 4
? Patients not expected to live more than 4 weeks
?Curative or palliative operation
?Hilar or perihilar biliary obstruction
?Endoscopic nasobiliary drainage, endoscopic retrograde biliary drainage, or percutaneous transhepatic biliary drainage before secondary metal stent insertion
?Covered metal stent insertion as a first stent
?Obstruction of first stent caused by migration of food impaction.

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
stent patency
Secondary Outcome Measures
NameTimeMethod
Time to stent occlusion;Median survival;Complication
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