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A Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction

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ClinicalTrials.gov Identifier: NCT02659852
Recruitment Status : Unknown
Verified January 2019 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : January 20, 2016
Last Update Posted : January 28, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief Summary:

Malignant obstructive jaundice is a common complication of advanced stage cholangiocarcinoma, GB cancer, and pancreatic cancer. In biliary stricture by malignancy, biliary drainage with placement of self-expanding metal stent (SEMS) for palliation is the therapy of choice in these patients. On hilar biliary malignant obstruction, bilateral stent used to be inserted. There are two kinds of bilateral metal stent insertion methods in hilar biliary malignant obstruction. (Stent in stent vs. side by side) Previously, two studies was conducted to show the superiority of bilateral metal stent insertion between stent in stent and side by side. Biliary drainage and stent patency was a little superior in side by side than stent in stent. But, complication related with bilateral metal stent was increased in patients with side by side method. Another study showed that there was no significant difference between those bilateral stent insertion methods. The most important concern about side by side method is associated with portal vein thrombosis by bilateral stent diameter. Selection of proper stent insertion method in patients with hilar malignant biliary obstruction is still controversial.

The purpose of this study is to investigate the patency of stent and survival of patients in side by side method (6mm sized M type) compared to stent in stent method (10mm sized LCD type) in patient with hilar malignant biliary obstruction.


Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Gallbladder Cancer Pancreatic Cancer HCC AOV Cancer Procedure: side by side Procedure: stent in stent Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study for Efficacy of Side-by-side Compared to Stent-in-stent Technique in the Endoscopic Management of Malignant Hilar Biliary Obstruction
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Side by side group Procedure: side by side
Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.
Active Comparator: Stent in stent group Procedure: stent in stent
After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.


Outcome Measures
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Primary Outcome Measures :
  1. Median patency duration [ Time Frame: 1 year after stent insertion ]
    Median patency duration from stent insertion date to stent occlusion date or last follow up date if stent is patent


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
  2. complication rate [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed hilar malignant biliary obstruction or clinically defined malignant biliary obstruction
  • older than 20 years old

Exclusion Criteria:

  • Operable case
  • Non-hilar biliary malignant obstruction
  • Duodenal obstruction
  • Other cancer except biliary malignancy
  • uncontrolled infection status
  • Eastern Cooperative Oncology Group ≥ 3
  • No signed informed consent
  • Failed endoscopic approach to duodenum or biliary tract
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): NCT02659852


Locations
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Korea, Republic of
Severance Hospital, Yonsei University Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Seungmin Bang, MD    02-2228-5412    Bang7028@yuhs.ac   
Contact: Moonjae Chung, MD    82-10-5058-6865    mjchung@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Publications:

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02659852    
Other Study ID Numbers: 4-2015-1072
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yonsei University:
Hilar malignant biliary obstruction
bilateral metal stent
stent in stent
side by side
Additional relevant MeSH terms:
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Cholangiocarcinoma
Gallbladder Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Adenocarcinoma
 Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Biliary Tract Neoplasms
Biliary Tract Diseases
Gallbladder Diseases