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Clinical Trials/NCT01413386
NCT01413386
Terminated
Not Applicable

A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.

Jong Taek, Lee3 sites in 1 country74 target enrollmentSeptember 2011
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ConditionsBiliary StrictureMalignant Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Biliary Stricture
Sponsor
Jong Taek, Lee
Enrollment
74
Locations
3
Primary Endpoint
Accumulative Patency Rate
Status
Terminated
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Detailed Description

Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
April 23, 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Jong Taek, Lee
Responsible Party
Sponsor Investigator
Principal Investigator

Jong Taek, Lee

Taewoong Medical Co., Ltd.

Taewoong Medical Co., Ltd.

Eligibility Criteria

Inclusion Criteria

  • •Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
  • •Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
  • •Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
  • •Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
  • •Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%)

Exclusion Criteria

  • •Patient who previously had surgical biliary drainage
  • •Patient who carrying bleeding disorder
  • •Patient who have combined Hilar and/or intra-hepatic duct cancer
  • •Patient who is improper to endoscopic treatment

Outcomes

Primary Outcomes

Accumulative Patency Rate

Time Frame: 6 months

Secondary Outcomes

  • Possibility of Other Treatment after Obstruction(6 months)
  • Accumulative Survival Rate(6 months)
  • Stent migration rate(6 months)

Study Sites (3)

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