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

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ClinicalTrials.gov Identifier: NCT01889953
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : May 25, 2015
Sponsor:
Collaborators:
Indiana University
University of Colorado, Denver
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
All India Institute of Medical Sciences, New Delhi
Winthrop University Hospital
University of Florida
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Erasmus Medical Center
Florida Hospital
Medical University of South Carolina
Institute of advanced endoscopy
Aichi Cancer Center
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University

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 this procedure.

Condition or disease Intervention/treatment Phase
Malignant Distal Biliary Obstruction Other: EUS-guided biliary drainage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Study Start Date : December 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 2015

Arm Intervention/treatment
EUS-guided biliary drainage
Patients in this arm will receive EUS-guided biliary drainage.
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. Number of required procedures [ Time Frame: From date of intervention up to death (These patients have a life expectancy of less than 2 years) ]
  4. 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


  5. 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

  6. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889953


Locations
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United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
Florida Hospital
Orlando, Florida, United States, 32803
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47405
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
India
All India Institute of Medical Sciences
Delhi, India, 110029
Institute of advanced endoscopy
Mumbai, India, 400036
Italy
Ismett/Upmc
Palermo, Italy, 90100
Japan
Aichi Cancer Center Hospital
Nagoya-shi, Aichi, Japan, 464-8681
Netherlands
Academic Medical Center of Amsterdam
Amsterdam, Netherlands, 1105
Erasmus Medical Center
Rotterdam, Netherlands, 3000
Sponsors and Collaborators
Johns Hopkins University
Indiana University
University of Colorado, Denver
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
All India Institute of Medical Sciences, New Delhi
Winthrop University Hospital
University of Florida
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Erasmus Medical Center
Florida Hospital
Medical University of South Carolina
Institute of advanced endoscopy
Aichi Cancer Center
Investigators
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Principal Investigator: Mouen A Khashab, MD Johns Hopkins Hospital Department of Gastroenterology

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mouen Khashab, Assistant Professor of Medicine; Director of Therapeutic Endoscopy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01889953     History of Changes
Other Study ID Numbers: NA_00077483
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: January 2015

Keywords provided by Mouen Khashab, Johns Hopkins University:
EUS-Guided Biliary Drainage
Endoscopic retrograde cholangiopancreatography
Malignant Biliary Obstruction