Single Versus Multiple Plastic Stents in Malignant Distal Bile Duct Obstruction

NCT ID: NCT03849859

Last Updated: 2021-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2020-11-30

Brief Summary

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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

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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

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Plastic Stent Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single plastic stent

Deployment of single plastic stent

Group Type ACTIVE_COMPARATOR

Single plastic stent

Intervention Type DEVICE

Deployment of single plastic stent

Multiple plastic stents

Deployment of multiple plastic stent

Group Type ACTIVE_COMPARATOR

Multiple plastic stents

Intervention Type DEVICE

Deployment of multiple plastic stents

Interventions

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Single plastic stent

Deployment of single plastic stent

Intervention Type DEVICE

Multiple plastic stents

Deployment of multiple plastic stents

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

In-operable distal malignant bile duct obstruction Age\>18

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Songkla University

OTHER

Sponsor Role lead

Responsible Party

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Nisa Netinatsunton

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ni Netinatsunton, M.D.

Role: PRINCIPAL_INVESTIGATOR

NKC Institute of Gastroenterology and Hepatology.

Locations

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NKC Institue of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

NKC Institues of Gastroenterology and Hepatology, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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REC.61-096-21-1

Identifier Type: -

Identifier Source: org_study_id

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