Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
NCT ID: NCT01041612
Last Updated: 2016-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
120 participants
INTERVENTIONAL
2010-01-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group A: C-SEMS, inserted above SO
-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
Group B: C-SEMS, inserted across SO
-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
Interventions
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PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
PTFE Covered ComVi [full covered] Biliary Stent
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis and it has 10 radiopaque markers; 4 in each end and 2 in the center.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Bile duct or gallbladder cancer invading CBD or distal CHD
* Pancreatic cancer with mid or distal CBD invasion
* Cancer should be 1.5 cm apart from bifurcation and 2 cm apart from ampulla of Vater.
* First attempt of endoscopic biliary metallic stenting
* Negative history of biliary tract surgery
* Life expectancy at least longer than 4 months (Karnofsky score \>60%)
Exclusion Criteria
* Klatskin tumor
* Combined intrahepatic bile duct cancer
* Patient with hemobilia
* Previous history of biliary drainage (endoscopic, percutaneous, surgical) except plastic stent or endoscopic nasobiliary drainage smaller than 7 Fr within 14 days
18 Years
ALL
No
Sponsors
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Taewoong Medical Co., Ltd.
INDUSTRY
Responsible Party
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Jong Taek, Lee
General manager
Principal Investigators
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Dong Ki Lee, PH.D
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Gifu University
Gifu, , Japan
Onomichi General Hospital
Onomichi, , Japan
Teine-Keijinkai Hospital
Sapporo, , Japan
The University of Tokyo
Tokyo, , Japan
Toho University
Tokyo, , Japan
Tokyo Medical University
Tokyo, , Japan
Yamaguchi University
Ube, , Japan
Soon Chun Hyang University School of Medicine
Bucheon-si, , South Korea
Soon Chun Hyang University School of Medicine
Cheonan, , South Korea
Catholic University of Daegu School of Medicine
Daegu, , South Korea
Inha University School of Medicine
Incheon, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Ajou University School of Medicine
Suwon, , South Korea
Countries
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References
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Jung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013
Other Identifiers
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RaMM-BO 2.0
Identifier Type: -
Identifier Source: org_study_id
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