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Self-expandable Metal Stents Versus Multiple Plastic Stents for Palliation of Biliary Obstruction

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03821025
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : February 20, 2019
Information provided by (Responsible Party):
Marc Bernon, University of Cape Town

Brief Summary:
A randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.

Condition or disease Intervention/treatment Phase
Bile Duct Obstruction, Extrahepatic Cancer of the Pancreas Cancer of the Bile Duct Biliary Stricture Device: Biliary stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Malignant Distal Biliary Obstruction - a Randomized Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Multiple Plastic Stents
Patients will receive two 8.5Fr Platic biliary stents placed side by side across the biliary stricture.
Device: Biliary stent
Palliation of malignant biliary obstruction

Active Comparator: Self-expandable Metal Stents
Patients will receive a fully covered Self-expandable Metal Stents (10mm) across the biliary stricture
Device: Biliary stent
Palliation of malignant biliary obstruction

Primary Outcome Measures :
  1. Number of patients without stent failure [ Time Frame: 12 months ]
    Number of patients without Stent failure (jaundice) or death with a patent stent

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 12 months ]
    Number of patietns alive in each group at 12 months

  2. Stent deployment failure [ Time Frame: During procedure ]
    Number of patients in whom there was failure to deploy the assigned stent(s) after randomisation

  3. Cost [ Time Frame: 12 months ]
    The differance in treatment costs between the two groups, measured in USD

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18years of age or older
  • informed consent obtained after oral and written information
  • clinical data in accordance with a malignant bile duct obstruction
  • imaging evidence: (ultrasonography (US), computed tomography (CT) or magnetic resonance imaging (MRI) shows signs of extrahepatic malignant common bile duct obstruction
  • typical ERCP findings of a malignant common bile duct stenosis
  • proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence
  • bilirubin > 50 micromol/L
  • radical surgery not deemed possible

Exclusion Criteria:

  • patients with active hepatitis or other jaundice-causing hepatic diseases
  • informed consent not obtained or patient unable to give informed consent
  • patients with no understanding of English, Afrikaans or Xhosa where it is not possible to obtain informed consent
  • metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria)
  • the patient is a possible candidate for surgical resection
  • suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations)
  • the proximal end of the stenosis is < 2 cm from the hepatic confluence
  • previous BII or Roux-en-Y gastric reconstruction
  • significant duodenal obstruction making ERCP difficult
  • previous bile duct stent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03821025

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Contact: Marc M Bernon, MBBCh +27 (0)21 404 3042

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South Africa
Groote Schuur Hospital Recruiting
Cape Town, Western Cape, South Africa, 7925
Contact: Marc M Bernon, MBBCh    +27 (0)21 404 3042   
Sponsors and Collaborators
University of Cape Town

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Responsible Party: Marc Bernon, Senior consultant, University of Cape Town Identifier: NCT03821025     History of Changes
Other Study ID Numbers: 661/2017
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Bile Duct Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Bile Duct Diseases
Biliary Tract Neoplasms
Cholestasis, Extrahepatic
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Biliary Tract Diseases