A Trial of Percutaneous vs. Endoscopic Drainage of Suspected Klatskin Tumors

Summary

The optimal approach to the drainage of malignant obstruction at the biliary hilum remains uncertain. This is a randomized comparative effectiveness study of percutaneous transhepatic biliary drainage (PTBD) vs. endoscopic retrograde cholangiography (ERC) as the first intervention in patients with cholestasis due to suspected malignant hilar obstruction.

Conditions

• Cholangiocarcinoma
• Hilar Lymphadenopathy
• Biliary Stricture

Interventions

PROCEDURE

PTBD

Percutaneous access and tube placement into the bile duct

PROCEDURE

ERC

Endoscopic access and stent placement in the bile duct

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• Vanderbilt University

  collaborator OTHER

• Stony Brook University

  collaborator OTHER

• University of Southern California

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Medical College of Wisconsin

  collaborator OTHER

• Dartmouth University

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• Johns Hopkins University

  collaborator OTHER

• Washington University School of Medicine

  collaborator OTHER

• University of Michigan

  collaborator OTHER

• Boston University

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Borland-Groover Clinic

  collaborator OTHER

• Methodist Health System

  collaborator OTHER

• St. Louis University

  collaborator OTHER

• Fox Chase Cancer Center

  collaborator OTHER

• Emory University

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Johns Hopkins Community Physicians

  collaborator OTHER

• University of Virginia

  collaborator OTHER

• Medical University of South Carolina

  lead OTHER

Principal Investigators

• B. Joseph Elmunzer · Medical University of South Carolina

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-20

Primary Completion

2019-04-12

Completion

2019-04-12

Countries

• United States

Study Locations