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

NCT02114320 | Completed Phase 3 DMC

• 1 other identifier: EUS-BD-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

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.

Conditions

Cholestasis, Extrahepatic

Keywords

Endoscopic ultrasonography; Biliary drainage; Metal stent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Complication rate of EUS-BD using metallic stents

  six months

Study Arms (2)

EUS-BD-1

EXPERIMENTAL

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

Device: EUS-BD

EUS-BD-2

EXPERIMENTAL

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

Device: EUS-BD

Interventions

EUS-BD DEVICE

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.

Also known as: 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

EUS-BD-1; EUS-BD-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• uncontrolled coagulopathy
• refuse to this study enrollment

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (2)

Tae Hoon Lee

Cheonan, 330-721, South Korea

Location

Woo Hyun Paik

Ilsan, South Korea

Location

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Interventions

Stents

Condition Hierarchy (Ancestors)

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Do Hyun Park, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 31, 2014
• First Posted: April 15, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-04

Locations

KR (2)