Efficacy and Safety of the Paclitaxel Eluting Covered Bil... | NCT01413386

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

NCT01413386

Sponsor

Jong Taek, Lee

Status

Terminated

Last Update Posted

Mar 11, 2020Actual

Enrollment

74Actual

Phase

Not Applicable

Conditions

Biliary Stricture
Malignant Neoplasms

Interventions

biliary stent

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Delayed subject enrollment

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Apr 18, 2013Actual

Completion Date

Apr 23, 2013Actual

First Submitted Date

Aug 9, 2011

First Submission Date that Met QC Criteria

Aug 9, 2011

First Posted Date

Aug 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Paclitaxel Eluting Covered Metal Stent	Experimental		Device: biliary stent
Covered Metal Stent	Active Comparator		Device: biliary stent

Interventions

Name	Type	Description	Arm Group Labels	Other Names
biliary stent	Device	palliative treatment for malignant patients	Covered Metal Stent Paclitaxel Eluting Covered Metal Stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accumulative Patency Rate		6 months

Secondary Outcomes

Measure	Description	Time Frame
Accumulative Survival Rate		6 months
Stent migration rate		6 months
Possibility of Other Treatment after Obstruction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Dong Ki Lee, Ph.D	Kangnam Severance Hospital	Study Chair
Mung Whan Kim, Ph.D	Asan Medical Center	Principal Investigator
Don Haeng Lee, Ph.D	Inha University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
In Ha University Hospital		Incheon	In Chun	400-711	South Korea
Kangnam Severance Hospital

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided