An interventional study of Single plastic stent and Multiple plastic stents in Plastic Stent Occlusion, sponsored by Prince of Songkla University. Terminated at 2 sites in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Prince of Songkla University · Not applicable, Interventional, and Treatment
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.
220 studies on the registry are indexed under Cholestasis; 37 are open to participants now.
This study's enrollment of 9 is below the median of 55 across 135 interventional studies indexed under Cholestasis.
Browse Cholestasis studies →Prince of Songkla University is the lead sponsor of 112 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
In-operable distal malignant bile duct obstruction Age>18
Exclusion Criteria:
Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Deployment of single plastic stent
Device: Single plastic stent
Deployment of multiple plastic stent
Device: Multiple plastic stents
Deployment of single plastic stent
Deployment of multiple plastic stents
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.
Plan to share: No
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This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Prince of Songkla University