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

May 22, 2015 updated by: Mouen Khashab, Johns Hopkins University
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.

Study Overview

Status

Completed

Intervention / Treatment

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 inoperable malignant distal biliary obstruction who have failed prior ERCP. Furthermore, EGBD may be associated with decreased procedure-related costs. Patients who undergo PTBD usually require multiple procedures for stent exchange/upsize. Our initial study will be a prospective multicenter feasibility study that will include patients with inoperable distal biliary obstruction who have failed ERCP. If feasibility is demonstrated, our goal will be to compare EGBD and PTBD in a randomized multicenter international trial with a crossover design.

Study Type

Interventional

Enrollment (Actual)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Mumbai, India, 400036
        • Institute of advanced endoscopy
      • Palermo, Italy, 90100
        • Ismett/Upmc
    • Aichi
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center of Amsterdam
      • Rotterdam, Netherlands, 3000
        • Erasmus Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Gainesville, Florida, United States, 32607
        • University of Florida
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Indiana
      • Bloomington, Indiana, United States, 47405
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: EUS-guided biliary drainage
Patients in this arm will receive 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness (Clinical success is defined as drop in bilirubin by 50%)
Time Frame: From date of intervention up to 4 weeks
Clinical success is defined as drop in bilirubin by 50% at 2 weeks and to below 3 (level
From date of intervention up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: From date of intervention up to 12 weeks
Determine improvement in QOL of patients after PTBD. QOL will be assessed using the EORTC-QLQ-30 instrument (at baseline, 1 week, 4 weeks and 12 weeks after the procedure).
From date of intervention up to 12 weeks
Procedure-related costs
Time Frame: Lifetime (These patients have a life expectancy of less than 2 years)
Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of PTBD in case of failed EGBD, cost of managing complications, cost of reintervention in case of stent occlusion, etc)
Lifetime (These patients have a life expectancy of less than 2 years)
Number of required procedures
Time Frame: From date of intervention up to death (These patients have a life expectancy of less than 2 years)
From date of intervention up to death (These patients have a life expectancy of less than 2 years)
Technical success
Time Frame: Intra- and post intervention (These patients have a life expectancy of less than 2 years)

This is defined as success of stent placement in the desired location as determined endoscopically and radiographically.

In addition, success of each step during EUS will be tracked and recorded (e.g. needle puncture, cholangiography, tract dilation, etc

Intra- and post intervention (These patients have a life expectancy of less than 2 years)
Stent patency
Time Frame: Lifetime (These patients have a life expectancy of less than 2 years)
Determine stent patency which is defined as time period between stent placement and need for reintervention for signs and symptoms of recurrent biliary obstruction
Lifetime (These patients have a life expectancy of less than 2 years)
Determine safety of EGBD (Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis)
Time Frame: Lifetime (These patients have a life expectancy of less than 2 years)
Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis
Lifetime (These patients have a life expectancy of less than 2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

June 26, 2013

First Posted (ESTIMATE)

July 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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