Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

Plastic Stent Occlusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03849859
• Other study ID #: REC.61-096-21-1
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: February 2019
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: November 30, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

In-operable distal malignant bile duct obstruction Age>18 Exclusion Criteria: Pregnancy ECOG 3-4 Can not correct coagulopathy Contraindicate for ERCP

Related Conditions & MeSH terms

• Cholestasis
• Plastic Stent Occlusion

Intervention

Device:
• Single plastic stent
Deployment of single plastic stent
• Multiple plastic stents
Deployment of multiple plastic stents

Locations

Country	Name	City	State
Thailand	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

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative stent patency	Proportion of patients with documented stent dysfunction	From the date of randomization though the study completion, assessed up to 1 year.
Primary	Clinical success rate	Proportion of patients with total bilirubin level declining > 50 % of the initial value	Four weeks after randomization
Secondary	Overall adverse events	Proportion of patients develop adverse events associated procedure included pancreatitis, cholangitis, hemorrhage.	From the date of randomization until the date of documented adverse events, assessed up to 1 month.
Secondary	Overall patient survival	Proportion of patients who die from any causes.	From the date of randomization until the date of death from any cause, assessed up to 12 months.
Secondary	Procedure relate death	Proportion of patients who die from complications related procedure.	From the date of randomization until the date of death from procedure within 7 days
Secondary	Technical success rate	Proportion of patient who successful underwent stent placement.	From the date of randomization until the last stent deploy, assessed up to 1 day.