Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

Prince of Songkla University

Status: Terminated

Conditions: Plastic Stent Occlusion

Treatments: Device: Single plastic stent; Device: Multiple plastic stents

Study type: Interventional

Funder types: Other

Identifiers

NCT03849859

REC.61-096-21-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In-operable distal malignant bile duct obstruction Age>18

Exclusion criteria

Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Single plastic stent

Active Comparator group

Description:

Deployment of single plastic stent

Treatment:

Device: Single plastic stent

Multiple plastic stents

Active Comparator group

Description:

Deployment of multiple plastic stent

Treatment:

Device: Multiple plastic stents