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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
AdventHealth
Medical University of South Carolina
Institute of advanced endoscopy
Aichi Cancer Center
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE December 4, 2012
First Posted Date  ICMJE July 1, 2013
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
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
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Determine safety of EGBD [ Time Frame: Lifetime (These patients have a life expectancy of less than 2 years) ]
Complications include the following: Bile leak, Perforation, Peritonitis, Cholecystitis, Cholangitis, Pancreatitis, Abdominal pain, Fever, Procedure-related Death, Hemorrhage, Liver laceration, Intraperitoneal stent migration, Supracapsular liver hematoma, Pneumoperitoneum, Sheared wire, Device failure. Severity of complications will be determined as described by Cotton et al. (A lexicon for endoscopic adverse events: report of an ASGE workshop)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2015)
  • 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).
  • 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)
  • Number of required procedures [ Time Frame: 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • Effectiveness [ 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 that allows patients to undergo chemotherapy) at 4 weeks
  • 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).
  • 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)
  • Number of required procedures [ Time Frame: 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
Official Title  ICMJE EUS-Guided Biliary Drainage in Patients With Inoperable Malignant Distal Biliary Obstruction and Failed ERCP: a Prospective Feasibility Multicenter Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Distal Biliary Obstruction
Intervention  ICMJE 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
Study Arms  ICMJE EUS-guided biliary drainage
Patients in this arm will receive EUS-guided biliary drainage.
Intervention: Other: EUS-guided biliary drainage
Publications * Khashab MA, Van der Merwe S, Kunda R, El Zein MH, Teoh AY, Marson FP, Fabbri C, Tarantino I, Varadarajulu S, Modayil RJ, Stavropoulos SN, Peñas I, Ngamruengphong S, Kumbhari V, Romagnuolo J, Shah R, Kalloo AN, Perez-Miranda M, Artifon EL. Prospective international multicenter study on endoscopic ultrasound-guided biliary drainage for patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography. Endosc Int Open. 2016 Apr;4(4):E487-96. doi: 10.1055/s-0042-102648. Epub 2016 Mar 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2015)
96
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
5
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India,   Italy,   Japan,   Netherlands,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01889953
Other Study ID Numbers  ICMJE NA_00077483
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mouen Khashab, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE
  • 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
  • AdventHealth
  • Medical University of South Carolina
  • Institute of advanced endoscopy
  • Aichi Cancer Center
Investigators  ICMJE
Principal Investigator: Mouen A Khashab, MD Johns Hopkins Hospital Department of Gastroenterology
PRS Account Johns Hopkins University
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP