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NCT Number: NCT01889953

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

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.

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Key information

Conditions

Malignant Distal Biliary Obstruction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences, Delhi, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

EUS-guided biliary drainage

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • AdventHealth
  • Aichi Cancer Center
  • All India Institute of Medical Sciences
  • Erasmus Medical Center
  • Indiana University
  • Institute of advanced endoscopy
  • Medical University of South Carolina
  • The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
  • University of Colorado, Denver
  • University of Florida
  • Winthrop University Hospital

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jul 1, 2013
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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