EUS Biliary Drainage vs. ERCP

August 9, 2023 updated by: Yen-I Chen, McGill University Health Centre/Research Institute of the McGill University Health Centre

EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial

Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

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

  • Canada
      • Montreal, Canada
        • Jewish General Hospital
    • Alberta
      • Calgary, Alberta, Canada
        • University of Calgary
      • Edmonton, Alberta, Canada
        • University of Alberta
    • Bristish Columbia
      • Vancouver, Bristish Columbia, Canada
        • Vancouver General Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • St-Paul Hospital
    • Ontario
      • Ottawa, Ontario, Canada
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5B 1W8
        • St-Michael's Hospital
    • Quebec
      • Montréal, Quebec, Canada, H3G 1A4
        • Mcgill University Health Centre
      • Montréal, Quebec, Canada, H2X3E4
        • Centre Hospitalier Universite de Montreal
      • Montréal, Quebec, Canada
        • Hopital Charles Lemoynes
  • France
      • Paris, France
        • Hopital Prive des Peupliers

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
  • Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
  • Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
  • Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
  • Karnofsky index > 30%
  • ASA score <IV
  • Provision of informed consent

Exclusion Criteria:

  • Hilar obstruction (biliary obstruction < 2 cm from the hilum)
  • Uncorrectable coagulopathy and/or thrombocytopenia
  • Age < 18
  • Liver metastasis involving > 30% of the liver volume
  • Liver cirrhosis with portal hypertension or ascites
  • Prior biliary sphincterotomy or stent placement
  • Surgically altered anatomy
  • Common bile duct measuring less than 1.2 cm will be excluded
  • Patient with clinical and radiological evidence of gastric outlet obstruction

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EUS-BD with LAMS
A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility is confirmed via EUS and with Doppler to rule out any intervening vessels. For common bile ducts < 15 mm in diameter, the biliary access is established via needle puncture with a 19-gauge needle followed by advancement of a 0.035 or 0.025 inch guidewire. A LAMS (AxiosTM) will then be inserted with cautery assistance without tract dilation and deployed. For common bile ducts > 15 mm, the need for initial needle puncture and wire insertion is at the discretion of the endoscopist. A cholangiogram is then performed through the LAMS with contrast injection. The choice of stent size will be at the discretion of the endoscopist (8 x 8 mm or 6 x 8 mm).
Procedure: EUS-BD with LAMS
Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy
Active Comparator: Traditional transpapillary metal stent via ERCP
A duodenoscope is advanced orally to the papilla. The bile duct is then cannulated with a sphincterotome using the guidewire-assisted technique. A cholangiogram is then performed followed by insertion of a self-expanding metal biliary stent. The performance of a biliary sphincterotomy prior to stent insertion and the choice of stent size (10x 40 mm, 10 x 60 mm, 10x 80 mm) will be at the discretion of the endoscopist.
Procedure: ERCP
Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of re-intervention
Time Frame: 1 year
Obstruction and/or migration of stent
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 1 year
successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization
1 year
Clinical success
Time Frame: 1 year
50% decrease in bilirubin < 2 weeks post-stent insertion or less than 25% of pre-procedure bilirubin level within 4 weeks post stent insertion
1 year
Stent patency
Time Frame: 1 year
mean time to stent obstruction or migration
1 year
Early adverse events
Time Frame: 1 year
as per the ASGE lexicon for endoscopic adverse events13 including post-procedural pancreatitis defined as new or worsening abdominal pain persistent for at least 24 hours and requiring analgesics after ERCP or EUS-BD with an elevated amylase or lipase of greater than three times the upper limit of normal, peri-procedural bleeding defined as hematemesis and/or melena or hemoglobin drop > 2 g, intestinal perforation defined as evidence of air or luminal contents outside the GI tract, and cholangitis >38 Celsius for greater than 24 hours with cholestatic liver enzymes
1 year

Collaborators and Investigators

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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

  • Principal Investigator: Yen-I Chen, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

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 (Actual)

March 8, 2019

Primary Completion (Actual)

May 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

March 9, 2019

First Submitted That Met QC Criteria

March 9, 2019

First Posted (Actual)

March 12, 2019

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • F11-36171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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