NCT02460432

Brief Summary

The purpose of this study is to compare the effectiveness and safety of Niti-S Mira-Cover III Biliary Stent with Comvi Biliary Covered Stent for the treatment of malignant biliary obstruction.

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 May 2015

Geographic Reach
1 country

5 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

May 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.7 years

First QC Date

May 26, 2015

Last Update Submit

April 7, 2017

Conditions

Biliary NeoplasmsBiliary ObstructionPancreatic Neoplasms

Keywords

Drug-eluting Biliary stentCovered metalic stent

Outcome Measures

Primary Outcomes (1)

  • Cumulative stent patency during 6months after stent placement

    Stent patency is defined as absence of stent obstruction and confirmed by computed tomography (CT) or ERCP.

    6 month

Secondary Outcomes (4)

  • Stent migration

    6 month

  • Secondary stent insertion due to recurrent biliary obstruction

    6 month

  • Mean survival

    6 month

  • Adverse events

    6 month

Study Arms (2)

Paclitaxel-eluting metal Stent

EXPERIMENTAL

Niti-S Mira-Cover III Biliary Stent (TaeWoong Medical Co., Ltd. Korea)

Device: Paclitaxel-eluting metal Stent

Covered Metal Stent

ACTIVE COMPARATOR

ComVi Biliary Covered Stent (TaeWoong Medical Co., Ltd. Korea)

Device: Covered Metal Stent

Interventions

Paclitaxel-eluting metal StentDEVICE

Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP

Paclitaxel-eluting metal Stent
Covered Metal StentDEVICE

Insertion of ComVi Biliary Covered Stent using ERCP

Covered Metal Stent

Eligibility Criteria

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

You may qualify if:

  • Age greater than or equal to 19 years of age
  • Malignant mid or distal biliary obstruction
  • Unresectable cancer
  • Estimated survival greater than or equal to 3 months (Karnofsky score ≥ 60)
  • Patient willing to provide written informed consent and comply with follow-up requirements

You may not qualify if:

  • Patients who had undergone surgical biliary drainage
  • Severe bleeding disorder (e.g. coagulopathy)
  • Polypoid lesion or intra-abdominal abscess
  • Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Inje University Busan Paik Hospital

Busan, Bokji-ro Busanjin-gu, 633-165, South Korea

Location

Seoul National University Hospital

Seoul, Haehak-ro Jongno-gu, 110-744, South Korea

Location

In Ha University Hospital

Incheon, Inhang-ro Jung-gu, 400-711, South Korea

Location

Samsung Medical Center

Seoul, Irwon-Dong, Gangnam-Gu, 130-710, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Related Publications (1)

  • Jang SI, Lee KT, Choi JS, Jeong S, Lee DH, Kim YT, Lee SH, Yu JS, Lee DK. Efficacy of a paclitaxel-eluting biliary metal stent with sodium caprate in malignant biliary obstruction: a prospective randomized comparative study. Endoscopy. 2019 Sep;51(9):843-851. doi: 10.1055/a-0754-5763. Epub 2018 Nov 9.

    PMID: 30414164DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Dong Ki Lee, Ph.D MD

    Gangnam Severance Hospital

    STUDY CHAIR

  • Kyu Taek Lee, Ph.D MD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Sang Hyub Lee, Ph.D MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

  • Don Haeng Lee, Ph.D MD

    In Ha University Hospital

    PRINCIPAL INVESTIGATOR

  • Jung Sik Choi, Ph.D MD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 2, 2015

Study Start

May 1, 2015

Primary Completion

December 26, 2016

Study Completion

December 26, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

February 12, 2016

Locations

KR(5)