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

Samsung Medical Center

Status: Unknown

Conditions: Biliary Tract Neoplasms

Treatments: Device: partially covered SEMS; Device: fully covered SEMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02255669

2014-07-187-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

partially covered SEMS

Active Comparator group

Description:

Deployment of Partially covered biliary self expandable metal stent

Treatment:

Device: partially covered SEMS

fully covered SEMS

Active Comparator group

Description:

Deployment of Fully covered biliary self expandable metal stent

Treatment:

Device: fully covered SEMS