Plastic Stent Occlusion
Conditions
Keywords
Plastic stent, Endoscopic Retrograde Cholangiopancreatography
Brief summary
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.
Detailed description
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.
Interventions
DEVICESingle plastic stent
Deployment of single plastic stent
DEVICEMultiple plastic stents
Deployment of multiple plastic stents
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
In-operable distal malignant bile duct obstruction Age\>18
Exclusion criteria
Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative stent patency | From the date of randomization though the study completion, assessed up to 1 year. | Proportion of patients with documented stent dysfunction |
| Clinical success rate | Four weeks after randomization | Proportion of patients with total bilirubin level declining \> 50 % of the initial value |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall adverse events | From the date of randomization until the date of documented adverse events, assessed up to 1 month. | Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage. |
| Overall patient survival | From the date of randomization until the date of death from any cause, assessed up to 12 months. | Proportion of patients who die from any causes. |
| Procedure relate death | From the date of randomization until the date of death from procedure within 7 days | Proportion of patients who die from complications related procedure. |
| Technical success rate | From the date of randomization until the last stent deploy, assessed up to 1 day. | Proportion of patient who successful underwent stent placement. |
Countries
Thailand
Outcome results
None listed