NCT01862198

Brief Summary

The purpose of this study is to investigate the feasibility and safety of endoscopic ultrasound-guided biliary drainage with a newly designed hybrid metallic stent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

2 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

September 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 2, 2013

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

May 19, 2013

Last Update Submit

November 29, 2013

Conditions

Bile Duct ObstructionDisorder of Bile Duct StentNeoplasms

Outcome Measures

Primary Outcomes (1)

  • The stent patency rate

    Up to 48 weeks

Secondary Outcomes (2)

  • Patients' survival rate

    Up to 48 weeks

  • Complication rate related to the hybrid stents

    Up to 48 weeks

Study Arms (1)

hybrid metallic stent

EXPERIMENTAL

Patients group who were inserted a hybrid metallic stent

Device: EUS-guided biliary drainage with a hybrid metallic stent

Interventions

EUS-guided biliary drainage with a hybrid metallic stentDEVICE

EUS-guided biliary drainage with a newly designed hybrid metallic stent

hybrid metallic stent

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 20 years
  • The presence of an unresectable malignant biliary obstruction
  • Failed conventional ERCP stenting

You may not qualify if:

  • Age \< 20 years
  • An inability to sedate the patient due to advanced heart or pulmonary diseases
  • A lack of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Inje University Ilsan Paik Hospital

Koyang, 411-706, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

CholestasisNeoplasms

Condition Hierarchy (Ancestors)

Bile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Sang Soo Lee, MD, PhD

    Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul , South Korea

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 19, 2013

First Posted

May 24, 2013

Study Start

September 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 2, 2013

Record last verified: 2013-11

Locations

KR(2)