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Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent | Clinical Trials | Clareo Health

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Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent

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.

NCT01413386•Jong Taek, Lee

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - 90 years

Sex

ALL

Healthy Volunteers

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

Locations (3)

In Ha University Hospital

Incheon, In Chun, South Korea

Kangnam Severance Hospital

Kangnam, Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Key Dates

Start Date

September 1, 2011

Primary Completion Date

April 18, 2013

Completion Date

April 23, 2013

Last Updated

March 11, 2020

Enrollment

ACTUAL participants

Conditions

Biliary StrictureMalignant Neoplasms

Interventions

biliary stent

DEVICE

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

NCT00026884

Malignant NeoplasmsHereditary Neoplastic Syndromes+3 more

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RECRUITINGPHASE2

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

NCT07407491

Acute CholangitisBiliary Tract Infection+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 11, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

Comparative Efficacy Of Intraductal Antibiotic During ERCP In Acute Cholangitis

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