Skip to main content
Clinical Trials/NCT02114320
NCT02114320CompletedPhase 3

Multicenter Study of EUS-guided Biliary Drainage Using Partially Covered With a Dedicated Introducer or Fully Covered Antimigration Metallic Stents

Asan Medical Center2 sites in 1 country32 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
32
Locations
2
Primary Endpoint
Technical success rate and procedural time of EUS-BD using metallic stents

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •uncontrolled coagulopathy
  • •refuse to this study enrollment

Arms & Interventions

EUS-BD-1

Experimental

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

Intervention: EUS-BD (Device)

EUS-BD-2

Experimental

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

Intervention: EUS-BD (Device)

Outcomes

Primary Outcomes

Technical success rate and procedural time of EUS-BD using metallic stents

Time Frame: six months

Measure the successful rate of biliary drainage using metallic stents and procedural time

Secondary Outcomes

  • Complication rate of EUS-BD using metallic stents(six months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Do Hyun Park

Dr

Asan Medical Center

Study Sites (2)

Loading locations...

Similar Trials