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

Not Applicable

Terminated

• Conditions: Malignant Neoplasms; Biliary Stricture
• Interventions: Device: biliary stent

• Registration Number: NCT01413386
• Lead Sponsor: Jong Taek, Lee

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.

Study Timeline

• Study First Submitted: 2011-08-09
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-10
• Study Start: 2011-09
• Primary Completion: 2013-04-18
• Study Completion: 2013-04-23
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Covered Metal Stent	biliary stent	-
Paclitaxel Eluting Covered Metal Stent	biliary stent	-

Primary Outcome Measures

Name	Time	Method
Accumulative Patency Rate	6 months

Secondary Outcome Measures

Name	Time	Method
Possibility of Other Treatment after Obstruction	6 months
Accumulative Survival Rate	6 months
Stent migration rate	6 months

Trial Locations

Locations (3)

In Ha University Hospital; 🇰🇷 Incheon, In Chun, Korea, Republic of

Kangnam Severance Hospital; 🇰🇷 Kangnam, Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of