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

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ClinicalTrials.gov Identifier: NCT02255669
Recruitment Status : Unknown
Verified September 2014 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : October 2, 2014
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Biliary Tract Neoplasms Device: partially covered SEMS Device: fully covered SEMS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Fully Covered and Partially Covered Self-expandable Metal Stents With Anti-migration System for Malignant Distal Biliary Obstruction
Study Start Date : October 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

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 Name: 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 Name: Insertion of fully covered SEMS (FCSEMS)




Primary Outcome Measures :
  1. duration of stent patency [ Time Frame: From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: From the date of randomization until the date of death from any cause, assessed upto 12 months ]
  2. stent occlusion rate [ Time Frame: From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months ]
  3. stent related complication [ Time Frame: From the date of randomization until the date of first documented stent related complication, assessed up to 12 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255669


Contacts
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Contact: Jong Kyun Lee, M.D., Ph.D. 82-2-3410-3409 leejk@skku.edu

Locations
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Korea, Republic of
Samsung Medical Cencer Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jong-Kyun Lee, M.D., Ph.D.    81-2-3410-3409    jongk.lee@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jong Kyun Lee, M.D., Ph.D. Samsung Medical Cencer
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Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02255669    
Other Study ID Numbers: 2014-07-187-001
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases