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

Completed · Not applicable

Conditions studied: Malignant Distal Biliary Obstruction

In brief

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.

Key facts

Study ID

NCT01889953

Run by

Johns Hopkins University

People needed

96

Starts

2012-12-01

Expected to finish

2015-01-01

Last updated by the study team

2015-05-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consecutive adult patients (18-80 years of age) with jaundice due to inoperable (by EUS and/or CT criteria or due to health status) malignant distal (more than 2cm distal to hilum) biliary obstruction and who have failed prior ERCP attempt. Failure is considered to be 2 unsuccessful attempts, according to each institution's definition of "failed" procedure (patients may be consented for EGBD prior to repeat ERCP due to higher likelihood of failure). One failure at outside institution and one failure at your institution can be considered as total of two failures.
• Ability to give informed consent

You may not qualify if…

• Unable to give informed consent
• Life expectancy < 1month
• Pregnant or breastfeeding women
• Acute gastrointestinal bleeding
• Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), or on chronic anticoagulation
• Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy.
• Prior total gastrectomy, Roux-en-Y gastric bypass, esophagectomy and sleeve gastrectomy
• ESLD with portal hypertension, varices, and/or ascites
• Liver metastases burden > 30%

Where it is running

• University of Colorado — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Indiana University — Bloomington, Indiana, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Winthrop University Hospital — Mineola, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• All India Institute of Medical Sciences — Delhi, India
• Institute of advanced endoscopy — Mumbai, India
• Ismett/Upmc — Palermo, Italy
• Aichi Cancer Center Hospital — Nagoya, Aichi-ken, Japan
• Academic Medical Center of Amsterdam — Amsterdam, Netherlands
• Erasmus Medical Center — Rotterdam, Netherlands

Full record on ClinicalTrials.gov

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