Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this prospective, randomized multicenter study is to determine whether there is any difference in stent patency of covered metallic stents in terms of stent positioning, above and across the sphincter of Oddi, in malignant bile duct obstruction.

Condition or disease	Intervention/treatment	Phase
Cancer of Bile Duct; Pancreatic Cancer	Device: PTFE Covered ComVi [full covered] Biliary Stent	Phase 4

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Single (Participant)
Primary Purpose:	Supportive Care
Official Title:	Prospective Randomized Trial Comparing Covered Metal Stents Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction: A Multi-nation, Multi-center Study
Study Start Date :	January 2010
Actual Primary Completion Date :	September 2012
Actual Study Completion Date :	September 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 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.	Device: 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 Name: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
Active Comparator: Group B: C-SEMS, inserted across SO; -In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.	Device: 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 Name: PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea

Outcome Measures

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Primary Outcome Measures :

1. Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange [ Time Frame: one year ]

Secondary Outcome Measures :

1. Death of patients [ Time Frame: one year ]

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Inoperable and/or unresectable cases of malignant stenosis at distal common hepatic duct or CBD, >= 18 years old
• 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:

• Ampullary cancer
• 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

Contacts and Locations

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Locations

Japan
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
Korea, Republic of
Soon Chun Hyang University School of Medicine
Bucheon, Korea, Republic of
Soon Chun Hyang University School of Medicine
Cheonan, Korea, Republic of
Catholic University of Daegu School of Medicine
Daegu, Korea, Republic of
Inha University School of Medicine
Incheon, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Ajou University School of Medicine
Suwon, Korea, Republic of

Sponsors and Collaborators

Taewoong Medical Co., Ltd.

Investigators

Principal Investigator:	Dong Ki Lee, PH.D	Gangnam Severance Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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

Responsible Party:	Jong Taek, Lee, General manager, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01041612 History of Changes
Other Study ID Numbers:	RaMM-BO 2.0
First Posted:	January 1, 2010
Last Update Posted:	October 21, 2016
Last Verified:	October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Jong Taek, Lee, Taewoong Medical Co., Ltd.:

CBD; HBD; cancer of bile duct; pancreatic cancer

Additional relevant MeSH terms:

Pancreatic Neoplasms; Bile Duct Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms	Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases