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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Biliary Tract Neoplasms

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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partially covered SEMS

Deployment of Partially covered biliary self expandable metal stent

Group Type ACTIVE_COMPARATOR

partially covered SEMS

Intervention Type DEVICE

Used for palliation of inoperable malignant distal bile duct obstruction.

fully covered SEMS

Deployment of Fully covered biliary self expandable metal stent

Group Type ACTIVE_COMPARATOR

fully covered SEMS

Intervention Type DEVICE

Used for palliation of inoperable malignant distal bile duct obstruction.

Interventions

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partially covered SEMS

Used for palliation of inoperable malignant distal bile duct obstruction.

Intervention Type DEVICE

fully covered SEMS

Used for palliation of inoperable malignant distal bile duct obstruction.

Intervention Type DEVICE

Other Intervention Names

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Insertion of partially covered SEMS (PCSEMS) Insertion of fully covered SEMS (FCSEMS)

Eligibility Criteria

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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

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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No