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Metal Versus Plastic Stent in Malignant Hilar Biliary Obstruction

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ClinicalTrials.gov Identifier: NCT03857958
Recruitment Status : Unknown
Verified April 2019 by Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : February 28, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
Taewoong Medical Co., Ltd.
Information provided by (Responsible Party):
Seoul National University Hospital

Study Description
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Brief Summary:
The purpose of this study was to compare the difference in the stent patency duration between side-by-side fully covered self-expanding metal stents (SEMS) and side-by-side plastic stents in patients with malignant hilar biliary obstruction.

Condition or disease Intervention/treatment Phase
Malignant Hepatobiliary Neoplasm Procedure: endoscopic retrograde cholangio-pancreatography Not Applicable

Detailed Description:
In the case of distal common bile duct obstruction, the SEMS was reported to be clinically superior to the plastic stent in previous studies. However, there are few studies comparing the two methods in patients with malignant hilar biliary obstruction. In contrast to the distal common bile duct obstruction, the advantage of plastic stents over SEMSs exists, and plastic stents are used commonly in real clinical practice.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Metal Versus Plastic Side-by-side Stent Insertion in Malignant Hilar Biliary Obstruction
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: FCSEMS
In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In FCSEMS group, patients are inserted with Fully covered self-expandable metal stent (FCSEMS) bilaterally for malignant hilar biliary stricture via endoscopic retrograde cholangio-pancreatography.
 Procedure: endoscopic retrograde cholangio-pancreatography
In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.
Other Names:
  • Plastic stent
  • FCSEMS
Active Comparator: Plastic stent
In patients with malignant hilar biliary obstruction, endoscopic drainage is performed for biliary drainage. Since intrahepatic bile ducts are separated, it is preferable to insert a stent into bilateral intrahepatic bile ducts for bile drainage if possible. In plastic stent group, patients are inserted with plastic stents bilaterally for malignant hilar biliary stricture.
 Procedure: endoscopic retrograde cholangio-pancreatography
In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.
Other Names:
  • Plastic stent
  • FCSEMS


Outcome Measures
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Primary Outcome Measures :
  1. Duration of stent patency [ Time Frame: 9 months after randomization. ]
    The period from the insertion of the stent to the point at which stent revision is required.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Unresectable malignant hilar biliary stricture requiring biliary drainage through endoscopic procedure

Exclusion Criteria:

  • If endoscopy is not possible based on the judgement of the researcher
  • Life expectancy less than 6 months
  • Acute cholecystitis
  • Previous history of percutaneous transhepatic biliary drainage
  • Previous history of metal stent placement for malignant biliary stricture
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03857958


Contacts
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Contact: Min su You, MD 82-2-2072-2228 bass105@hanmail.net
Contact: Woo Hyun Paik, MD, PhD 82-2-2072-2228 whpaik@snuh.org

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Min su You, MD    82-2-2072-2228    bass105@hanmail.net   
Contact: Woo Hyun Paik, MD, PhD    82-2-2072-2228    whpaik@snuh.org   
Sponsors and Collaborators
Seoul National University Hospital
Taewoong Medical Co., Ltd.
Investigators
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Principal Investigator: Seoul National University Hospital Seoul National University Hospital, MD, PhD Seoul National University Hospital
More Information
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03857958    
Other Study ID Numbers: 1812-098-996
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No