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

Biliary Tract Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02255669
• Other study ID #: 2014-07-187-001
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2014
• Last updated: February 10, 2015
• Start date: October 2014
• Est. completion date: October 2016

Study information

• Verified date: September 2014
• Source: Samsung Medical Center
• Contact: Jong Kyun Lee, M.D., Ph.D.
• Phone: 82-2-3410-3409
• Email: leejk[@]skku.edu
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Biliary Tract Neoplasms

Intervention

Device:
• partially covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.
• fully covered SEMS
Used for palliation of inoperable malignant distal bile duct obstruction.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Cencer	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	duration of stent patency		From the date of randomization until the date of first documented stent dysfunction, assessed upto 12 months	No
Secondary	overall survival		From the date of randomization until the date of death from any cause, assessed upto 12 months	No
Secondary	stent occlusion rate		From the date of randomization until the date of first documented stent occlusion, assessed up to 12 months	No
Secondary	stent related complication		From the date of randomization until the date of first documented stent related complication, assessed up to 12 months	Yes