Back to resultsComparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
Primary Purpose
Cancer of Bile Duct, Pancreatic Cancer
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
PTFE Covered ComVi [full covered] Biliary Stent
PTFE Covered ComVi [full covered] Biliary Stent
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Bile Duct focused on measuring CBD, HBD, cancer of bile duct, pancreatic cancer
Eligibility 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
Sites / Locations
- Gifu University
- Onomichi General Hospital
- Teine-Keijinkai Hospital
- The University of Tokyo
- Toho University
- Tokyo Medical University
- Yamaguchi University
- Soon Chun Hyang University School of Medicine
- Soon Chun Hyang University School of Medicine
- Catholic University of Daegu School of Medicine
- Inha University School of Medicine
- Gangnam Severance Hospital
- Ajou University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: C-SEMS, inserted above SO
Group B: C-SEMS, inserted across SO
Arm Description
-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
Outcomes
Primary Outcome Measures
Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
Secondary Outcome Measures
Death of patients
Full Information
NCT ID
NCT01041612
First Posted
December 28, 2009
Last Updated
October 19, 2016
Sponsor
Taewoong Medical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01041612
Brief Title
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
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 Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taewoong Medical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Bile Duct, Pancreatic Cancer
Keywords
CBD, HBD, cancer of bile duct, pancreatic cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: C-SEMS, inserted above SO
Arm Type
Active Comparator
Arm Description
-In group A, SO should be preserved without sphincterotomy, but small infundibulotomy with needle knife can be accepted for cannulation.
Arm Title
Group B: C-SEMS, inserted across SO
Arm Type
Active Comparator
Arm Description
-In group B, small sphincterotomy (50% incision) will be done after biliary cannulation.
Intervention Type
Device
Intervention Name(s)
PTFE Covered ComVi [full covered] Biliary Stent
Other Intervention Name(s)
PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
PTFE Covered ComVi [full covered] Biliary Stent
Other Intervention Name(s)
PTFE Covered ComVi [full covered] Biliary Stent, Taewoong Medical, Korea
Intervention Description
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.
Primary Outcome Measure Information:
Title
Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
Time Frame
one year
Secondary Outcome Measure Information:
Title
Death of patients
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ki Lee, PH.D
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gifu University
City
Gifu
Country
Japan
Facility Name
Onomichi General Hospital
City
Onomichi
Country
Japan
Facility Name
Teine-Keijinkai Hospital
City
Sapporo
Country
Japan
Facility Name
The University of Tokyo
City
Tokyo
Country
Japan
Facility Name
Toho University
City
Tokyo
Country
Japan
Facility Name
Tokyo Medical University
City
Tokyo
Country
Japan
Facility Name
Yamaguchi University
City
Ube
Country
Japan
Facility Name
Soon Chun Hyang University School of Medicine
City
Bucheon
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University School of Medicine
City
Cheonan
Country
Korea, Republic of
Facility Name
Catholic University of Daegu School of Medicine
City
Daegu
Country
Korea, Republic of
Facility Name
Inha University School of Medicine
City
Incheon
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Ajou University School of Medicine
City
Suwon
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
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
Results Reference
result
Learn more about this trial
Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
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