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

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

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.

Study Overview

• Status: Completed
• Conditions: Cholestasis, Extrahepatic
• Intervention / Treatment: Device: EUS-BD

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Cheonan, Korea, Republic of, 330-721
    • Tae Hoon Lee
  • Ilsan, Korea, Republic of
    • Woo Hyun Paik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• uncontrolled coagulopathy
• refuse to this study enrollment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EUS-BD-1; EUS-BD-1 inserts a partially covered self-expanding metallic (hybrid) stent with a dedicated introducer for EUS-BD	Device: EUS-BD; 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.; Other Names: 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
Experimental: EUS-BD-2; EUS-BD-2 inserts a fully covered self-expanding metallic stent	Device: EUS-BD; 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.; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate of EUS-BD using metallic stents	Measure the complication rate of EUS-BD using metallic stents	six months

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Investigators: Principal Investigator: Do Hyun Park, MD, PhD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: March 31, 2014
• First Submitted That Met QC Criteria: April 12, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Endoscopic ultrasonography; Biliary drainage; Metal stent
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholestasis; Cholestasis, Extrahepatic
• Other Study ID Numbers: EUS-BD-001