Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

Not Applicable

Terminated

• Conditions: Plastic Stent Occlusion
• Interventions: Device: Single plastic stent; Device: Multiple plastic stents

• Registration Number: NCT03849859
• Lead Sponsor: Prince of Songkla University

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.

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2019-05-01
• Primary Completion: 2020-05-01
• Study Completion: 2020-11-30
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

In-operable distal malignant bile duct obstruction Age>18

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single plastic stent	Single plastic stent	Deployment of single plastic stent
Multiple plastic stents	Multiple plastic stents	Deployment of multiple plastic stent

Primary Outcome Measures

Name	Time	Method
Clinical success rate	Four weeks after randomization	Proportion of patients with total bilirubin level declining \> 50 % of the initial value
Cumulative stent patency	From the date of randomization though the study completion, assessed up to 1 year.	Proportion of patients with documented stent dysfunction

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (2)

NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University; 🇹🇭 Hat Yai, Songkla, Thailand

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University; 🇹🇭 Hat Yai, Songkhla, Thailand