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Completed

NCT Number: NCT03870386

EUS Biliary Drainage vs. ERCP

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.

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Key information

Conditions

Biliary Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

EUS-BD with LAMS

Procedure

Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy

ERCP

Procedure

Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.

Primary outcomes

  1. Rate of re-intervention

    Time frame: 1 year

    Obstruction and/or migration of stent

Secondary outcomes

  1. Technical success

    Time frame: 1 year

    successful insertion of a transpapillary stent or choledochoduodenostomy stent at the initial procedure at time of randomization

  2. 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

  3. Stent patency

    Time frame: 1 year

    mean time to stent obstruction or migration

  4. 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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2019
Registry last updated
Aug 14, 2023

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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