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Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents

Primary Purpose

Cholestasis, Extrahepatic

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EUS-BD
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholestasis, Extrahepatic focused on measuring Endoscopic ultrasonography, Biliary drainage, Metal stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • malignant biliary obstruction
  • Inoperable state
  • age > 18 yrs
  • failed primary ERCP

Exclusion Criteria:

  • uncontrolled coagulopathy
  • refuse to this study enrollment

Sites / Locations

  • Tae Hoon Lee
  • Woo Hyun Paik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

EUS-BD-1

EUS-BD-2

Arm Description

EUS-BD-1 inserts a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD

EUS-BD-2 inserts a fully covered self-expanding metallic stent

Outcomes

Primary Outcome Measures

Technical success rate and procedural time of EUS-BD using metallic stents
Measure the successful rate of biliary drainage using metallic stents and procedural time

Secondary Outcome Measures

Complication rate of EUS-BD using metallic stents
Measure the complication rate of EUS-BD using metallic stents

Full Information

First Posted
March 31, 2014
Last Updated
December 2, 2014
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02114320
Brief Title
Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents
Official Title
Multicenter Study of EUS-guided Biliary Drainage Using Partially Covered With a Dedicated Introducer or Fully Covered Antimigration Metallic Stents
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Although endoscopic retrograde cholangiopancreatography (ERCP) is almost always successful in patients with malignant biliary obstruction, selective biliary cannulation fails in some cases and conventional ERCP may not be possible in patients with tumor invasion of the duodenum or major papilla, surgically altered anatomy (e.g., Roux-en-Y anastomosis), or complex hilar biliary strictures. In such cases, percutaneous transhepatic biliary drainage (PTBD) is an useful alternative. However, PTBD had various complications and the presence of an external drainage catheter would also have a cosmetic problem related to the external drainage and an adverse impact on quality of life (QOL) of terminally ill patients. Since endoscopic ultrasound-guided bile duct puncture was described in 1996, sporadic case reports of EUS-guided biliary drainage (EUS-BD) suggested that it was a feasible and effective alternative in patients with failed conventional ERCP stenting. The potential benefits of EUS-BD include one-stage procedure in ERCP unit, and internal drainage for avoiding long-term external drainage in cases where external PTBD drainage catheters cannot be internalized, thus significantly improving the QOL of terminally ill patients, and possibly lower morbidity than PTBD or surgery. Up to date, only a few case series of EUS-BD with small numbers of patients have been published, and known the feasibility and safety in terms of the incidence of procedure-related clinical outcomes.
Detailed Description
We investigated the efficacy and safety of EUS-BD using partially covered (hybrid) metallic stent with a dedicated introducer for EUS-BD, or fully covered antimigration metallic stents in malignant biliary obstruction after failed conventional ERCP as a prospective multicenter study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholestasis, Extrahepatic
Keywords
Endoscopic ultrasonography, Biliary drainage, Metal stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EUS-BD-1
Arm Type
Experimental
Arm Description
EUS-BD-1 inserts a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD
Arm Title
EUS-BD-2
Arm Type
Experimental
Arm Description
EUS-BD-2 inserts a fully covered self-expanding metallic stent
Intervention Type
Device
Intervention Name(s)
EUS-BD
Other Intervention Name(s)
EUS-BD-1: a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD, EUS-BD-2: a fully covered self-expanding metallic stent
Intervention Description
EUS-guided hepaticogastrostomy (EUS-HG) will be performed in patients with hilar stricture or altered anatomy such as Roux-en-Y anastomosis, and EUS-guided choledochoduodenostomy (EUS-CD) will be performed in patients with mid to distal extrahepatic bile duct strictures. Because EUS-guided rendezvous technique can be attempted only in patients in whom the papilla is endoscopically accessible. Following bile duct puncture using a 19-gauge fine needle, one-step or graded tract dilatation will be performed. Then, finally we insert a partially or fully covered metallic stent.
Primary Outcome Measure Information:
Title
Technical success rate and procedural time of EUS-BD using metallic stents
Description
Measure the successful rate of biliary drainage using metallic stents and procedural time
Time Frame
six months
Secondary Outcome Measure Information:
Title
Complication rate of EUS-BD using metallic stents
Description
Measure the complication rate of EUS-BD using metallic stents
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: malignant biliary obstruction Inoperable state age > 18 yrs failed primary ERCP Exclusion Criteria: uncontrolled coagulopathy refuse to this study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Do Hyun Park, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tae Hoon Lee
City
Cheonan
ZIP/Postal Code
330-721
Country
Korea, Republic of
Facility Name
Woo Hyun Paik
City
Ilsan
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Outcomes of EUS-guided Biliary Drainage Using Partially or Fully Covered Metallic Stents

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