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

February 10, 2015 updated by: Samsung Medical Center

Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jong Kyun Lee, M.D., Ph.D.
  • Phone Number: 82-2-3410-3409
  • Email: leejk@skku.edu

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: partially covered SEMS
Deployment of Partially covered biliary self expandable metal stent
Device: partially covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
Other Names:
  • Insertion of partially covered SEMS (PCSEMS)
ACTIVE_COMPARATOR: fully covered SEMS
Deployment of Fully covered biliary self expandable metal stent
Device: fully covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
Other Names:
  • Insertion of fully covered SEMS (FCSEMS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
duration of stent patency
Time Frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months
From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: From the date of randomization until the date of death from any cause, assessed upto 12 months
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
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
From the date of randomization until the date of first documented stent related complication, assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jong Kyun Lee, M.D., Ph.D., Samsung Medical Cencer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ANTICIPATED)

October 1, 2016

Study Completion (ANTICIPATED)

October 1, 2016

Study Registration Dates

First Submitted

September 30, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (ESTIMATE)

October 2, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 10, 2015

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-07-187-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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