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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • India
      • Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Mumbai, India, 400036
        • Institute of advanced endoscopy
  • Italy
      • Palermo, Italy, 90100
        • Ismett/Upmc
  • Japan
    • Aichi
      • Nagoya-shi, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105
        • Academic Medical Center of Amsterdam
      • Rotterdam, Netherlands, 3000
        • Erasmus Medical Center
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical University of South Carolina
University of Colorado, Denver
All India Institute of Medical Sciences, New Delhi
University of Florida
Erasmus Medical Center
Indiana University
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
AdventHealth
Winthrop University Hospital
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Aichi Cancer Center
Institute of advanced endoscopy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mouen A Khashab, MD, Johns Hopkins Hospital Department of Gastroenterology

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NA_00077483

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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