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

NCT ID: NCT02114320

Last Updated: 2014-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-10-31

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.

Conditions

Cholestasis, Extrahepatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

EUS-BD-1

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

Group Type: EXPERIMENTAL

EUS-BD

Intervention Type: 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.

EUS-BD-2

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

Group Type: EXPERIMENTAL

EUS-BD

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention 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

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• uncontrolled coagulopathy
• refuse to this study enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Do Hyun Park

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Do Hyun Park, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Tae Hoon Lee

Cheonan, , South Korea

Woo Hyun Paik

Ilsan, , South Korea

Countries

South Korea

Other Identifiers

EUS-BD-001

Identifier Type: -

Identifier Source: org_study_id