Status:
COMPLETED
EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Indiana University
University of Colorado, Denver
Conditions:
Malignant Distal Biliary Obstruction
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 t...
Detailed Description
Our central hypothesis is that EGBD is equally effective and safe to percutaneous transhepatic biliary drainage (PTBD) but is associated with better quality of life than PTBD in patients with inoperab...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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%
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01889953
Start Date
December 1 2012
End Date
January 1 2015
Last Update
May 25 2015
Active Locations (13)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
University of Florida
Gainesville, Florida, United States, 32607
3
Florida Hospital
Orlando, Florida, United States, 32803
4
Indiana University
Bloomington, Indiana, United States, 47405