EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial

Summary

This research is being done to study the safety and feasibility of recruiting patients eligible for EUS-guided biliary drainage (EGBD). Our goal is to prospectively study safety and effectiveness of this procedure.

Conditions

• Malignant Distal Biliary Obstruction

Interventions

OTHER

EUS-guided biliary drainage

Based on the patient's condition, the will receive: * Rendezvous technique * Direct transluminal access transesophageal technique * Direct transluminal access transduodenal technique * or direct transluminal access using transgastric approach

Sponsors & Collaborators

• Indiana University

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• All India Institute of Medical Sciences

  collaborator OTHER

• Winthrop University Hospital

  collaborator OTHER

• University of Florida

  collaborator OTHER

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• AdventHealth

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• Institute of advanced endoscopy

  collaborator UNKNOWN

• Aichi Cancer Center

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Mouen A Khashab, MD · Johns Hopkins Hospital Department of Gastroenterology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-31

Primary Completion

2014-12-31

Completion

2015-01-31

Countries

• United States
• India
• Italy
• Japan
• Netherlands

Study Locations