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

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

Study Description

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.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Contacts

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

Locations

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

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

More Information

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT02255669
• Other Study ID Numbers: 2014-07-187-001
• First Posted: October 2, 2014
• Last Update Posted: February 12, 2015
• Last Verified: September 2014

Additional relevant MeSH terms:

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases