Fully Covered SEMS Versus Partially Covered SEMS With Anti-migration System for Malignant Distal Biliary Obstruction

Not Applicable

• Conditions: Biliary Tract Neoplasms
• Interventions: Device: partially covered SEMS; Device: fully covered SEMS

• Registration Number: NCT02255669
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to compare the duration of stent patency between partially covered and fully covered SEMS for palliation of malignant distal bile duct obstruction.

Detailed Description

Endoscopic stent placement has been used as a principle palliative method in patients with unresectable distal malignancy biliary obstruction. It has been pivotal in providing relief from obstructive jaundice, improving the quality of life, and allowing the maintenance of chemotherapy. Although SEMSs have been reported to be superior to plastic stents in terms of stent patency, they still have some debatable issues ; in uncovered SEMS, stent occlusion due to epithelial hyperplasia and tumor ingrowth through the metal mesh is a frequent problem, whereas covered SEMSs are prone to migration.

The aim of the current study is to compare the duration of stent patency between partially covered and fully covered SEMS as a primary objective, and investigate overall patient survival, stent occlusion rate, and incidence of adverse events including stent dysfunction as secondary objectives.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-09
• Study First Submitted: 2014-09-30
• Study First Submitted QC: 2014-09-30
• Study Start: 2014-10
• Study First Posted: 2014-10-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-12
• Primary Completion: 2016-10
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• 1.> 19years 2.malignant biliary obstruction, 2 cm distal to hilum 3.unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal

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Exclusion Criteria

• 1.history of biliary surgery except cholecystectomy 2.history of SEMS placement 3.coagulopathy (INR>1.5, Platelet<50000) 4.expected survival > 3 months based on Karnofsky performance score 5.duodenal stricture

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
partially covered SEMS	partially covered SEMS	Deployment of Partially covered biliary self expandable metal stent
fully covered SEMS	fully covered SEMS	Deployment of Fully covered biliary self expandable metal stent

Primary Outcome Measures

Name	Time	Method
duration of stent patency	From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months

Secondary Outcome Measures

Name	Time	Method
stent occlusion rate	From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months
stent related complication	From the date of randomization until the date of first documented stent related complication, assessed up to 12 months
overall survival	From the date of randomization until the date of death from any cause, assessed upto 12 months

Trial Locations

Locations (1)

Samsung Medical Cencer; 🇰🇷 Seoul, Korea, Republic of