NCT03849859

Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

A Prospective Randomized Trial Comparing Single Plastic Stent Versus Multiple Plastic Stents in Inoperable Malignant Distal Bile Duct Obstruction.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Prince of Songkla University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Plastic Stent Occlusion

Interventions

Type	Name	Description
DEVICE	Single plastic stent	Deployment of single plastic stent
DEVICE	Multiple plastic stents	Deployment of multiple plastic stents

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-05-01
• Completion: 2020-11-30
• First posted: 2019-02-21
• Last updated: 2021-04-01

Locations

2 sites across 1 country: Thailand