Endoscopic retrograde cholangiopancreatography (ERCP) with biliary stent placement is crucial for palliative treatment in patients with malignant bile duct obstruction who cannot perform surgery due to advanced diseases or associated comorbidities. Stent patency is challenge in ERCP. Self expanding metallic stents (SEMS) have a longer duration of patency and fewer of recurrence occlusion of stent when compared with plastic stent (PS). However, the cost of MS is more expensive than PS about 4 times. Therefore, many patients cannot afford the MS due to their economic status. Data regarding the efficacy and safety of multiple PS compared with single PS for the palliative treatment in unresectable malignant distal bile duct obstruction are limited.
The aim of the current study is to compare the cumulative stent patency of multiple PS and single plastic stent and the clinical success rate as a primary objective, investigate the technical success rate, procedure time incident of overall adverse events including stent dysfunction and overall procedure related mortality as secondary outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Deployment of single plastic stent
Deployment of multiple plastic stents
NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand
Cumulative stent patency
Proportion of patients with documented stent dysfunction
Time frame: From the date of randomization though the study completion, assessed up to 1 year.
Clinical success rate
Proportion of patients with total bilirubin level declining \> 50 % of the initial value
Time frame: Four weeks after randomization
Overall adverse events
Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.
Time frame: From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Overall patient survival
Proportion of patients who die from any causes.
Time frame: From the date of randomization until the date of death from any cause, assessed up to 12 months.
Procedure relate death
Proportion of patients who die from complications related procedure.
Time frame: From the date of randomization until the date of death from procedure within 7 days
Technical success rate
Proportion of patient who successful underwent stent placement.
Time frame: From the date of randomization until the last stent deploy, assessed up to 1 day.
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