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

Samsung Medical Center106 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

106

Conditions

Biliary Tract Neoplasms

Interventions

partially covered SEMSDEVICE

Used for palliation of inoperable malignant distal bile duct obstruction.

fully covered SEMSDEVICE

Used for palliation of inoperable malignant distal bile duct obstruction.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Cencer

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

duration of stent patency

Time frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months

Secondary Outcomes

overall survival

Time frame: From the date of randomization until the date of death from any cause, assessed upto 12 months

stent occlusion rate

Time frame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months

stent related complication

Time frame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months

Central Contacts

Jong Kyun Lee, M.D., Ph.D.

CONTACT

82-2-3410-3409 leejk@skku.edu

Data from ClinicalTrials.gov

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