NCT01512563

Brief Summary

Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common Covered Metallic Biliary Stent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2012

Completed
Last Updated

March 11, 2020

Status Verified

January 1, 2012

Enrollment Period

3 years

First QC Date

January 11, 2012

Last Update Submit

March 9, 2020

Conditions

Biliary StrictureMalignant Neoplasms

Keywords

paclitaxeldrug eluting stent

Outcome Measures

Primary Outcomes (1)

  • Accumulative Patency Rate

    6 month

Secondary Outcomes (3)

  • Accumulative Survival Rate

    6 months

  • Complications

    6 months

  • Possibility of Other Treatment after Obstruction

    6 months

Study Arms (2)

Paclitaxel ElutingCovered Metal Stent

EXPERIMENTAL
Device: Biliary stent

Covered Metal Stent

ACTIVE COMPARATOR
Device: Biliary stent

Interventions

Biliary stentDEVICE

palliative treatment for malignant patients

Also known as: Niti-S Mira-Cover Biliary Stent, Niti-S Biliary Stent
Covered Metal StentPaclitaxel ElutingCovered Metal Stent

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who is inoperable and/or unresectable cases of pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
  • Among patient of a.,Patient who previously had surgical biliary drainage of plastic stent have eligibility

You may not qualify if:

  • Patient who have life expectancy under 3 months
  • Patient who have severe metastasis of Liver or whole body
  • Patient who previously had surgical biliary drainage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

Location

Catholic University of Daegu School of Medicine

Daegu, South Korea

Location

Kangnam Severance Hospital

Seoul, 135-720, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Dong Ki Lee, Ph.D

    Kangnam Severance Hospital

    STUDY CHAIR

  • Ho Gak Kim

    Catholic University of Daegu School of Medicine

    PRINCIPAL INVESTIGATOR

  • Sang Heum Park

    Soon Chun Hyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2012

First Posted

January 19, 2012

Study Start

February 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

March 11, 2020

Record last verified: 2012-01

Locations

KR(3)