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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Taewoong Medical Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01041612
First received: December 28, 2009
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Cancer of Bile Duct
Pancreatic Cancer
Device: PTFE Covered ComVi [full covered] Biliary Stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Taewoong Medical Co., Ltd.:

Primary Outcome Measures:
  • Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death of patients [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: January 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041612

Locations
Japan
Gifu University Recruiting
Gifu, Japan
Contact: Yasuda Ichiro, PH.D    +81-90-8072-4480    yasudaic@aol.com   
Principal Investigator: Yasuda Ichiro, PH.D         
Onomichi General Hospital Recruiting
Onomichi, Japan
Contact: Hanada Keiji, PH.D    +81-848-24-8811    Kh-ajpbd@nifty.com   
Principal Investigator: Hanada Keiji, PH.D         
Teine-Keijinkai Hospital Recruiting
Sapporo, Japan
Contact: Maguchi Hiroyuki, PH.D    +81-11-681-8111    maguchi@tb3.so-net.ne.jp   
Principal Investigator: Maguchi Hiroyuki, PH.D         
The University of Tokyo Recruiting
Tokyo, Japan
Contact: Isayama Hiroyuki, PH.D    +81 90-5318-0775    isayama-2im@h.u-tokyo.ac.jp   
Principal Investigator: Isayama Hiroyuki, PH.D         
Toho University Recruiting
Tokyo, Japan
Contact: Maetani Iruru, PH.D    +81-3-3468-1251    mtnir50637@med.toho-u.ac.jp   
Principal Investigator: Maetani Iruru, PH.D         
Tokyo Medical University Recruiting
Tokyo, Japan
Contact: Itoi Takao, PH.D    +81-90-8774-1212    itoi@tokyo-med.ac.jp   
Principal Investigator: Itoi Takao, PH.D         
Yamaguchi University Recruiting
Ube, Japan
Contact: Ryozawa Shomei, PH.D    +81-90-5086-2902    ryozawa@yamaguchi-u.ac.jp   
Principal Investigator: Ryozawa Shomei, PH.D         
Korea, Republic of
Soon Chun Hyang University School of Medicine Recruiting
Bucheon, Korea, Republic of
Contact: Jong Ho Moon, PH.D    +82-11-9715-3543    jhmoon@schbc.ac.kr   
Principal Investigator: Jong Ho Moon, PH.D         
Soon Chun Hyang University School of Medicine Recruiting
Cheonan, Korea, Republic of
Contact: Sang Heum Park, PH.D    +82-41-570-3678    ppargsh@sch.ac.kr   
Principal Investigator: Sang Heum Park, PH.D         
Catholic University of Daegu School of Medicine Recruiting
Daegu, Korea, Republic of
Contact: Ho Gak Kim, PH.D    +82-10-3503-4659    hgkim@cu.ac.kr   
Principal Investigator: Ho Gak Kim, PH.D         
Inha University School of Medicine Recruiting
Incheon, Korea, Republic of
Contact: Don Haeng Lee, PH.D    +82-32-890-2548    idh@inha.ac.kr   
Principal Investigator: Don Haeng Lee, PH.D         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 135-720
Contact: Dong Ki Lee, Ph.D    +82-11-9057-8804    dklee@yuhs.ac   
Principal Investigator: Dong Ki Lee, PH.D         
Ajou University School of Medicine Recruiting
Suwon, Korea, Republic of
Contact: Jin Hong Kim, PH.D    +82-011-280-3131    jinhkim@ajou.ac.kr   
Principal Investigator: Jin Hong Kim, PH.D         
Sponsors and Collaborators
Taewoong Medical Co., Ltd.
Investigators
Principal Investigator: Dong Ki Lee, PH.D Gangnam Severance Hospital
  More Information

No publications provided

Responsible Party: Dong ki, Lee, M.D,Ph.D. Professor, Gangnam Severance Hospital
ClinicalTrials.gov Identifier: NCT01041612     History of Changes
Other Study ID Numbers: RaMM-BO 2.0
Study First Received: December 28, 2009
Last Updated: August 8, 2011
Health Authority: Korea: Institutional Review Board
Japan: Institutional Review Board

Keywords provided by Taewoong Medical Co., Ltd.:
CBD
HBD
cancer of bile duct
pancreatic cancer

Additional relevant MeSH terms:
Bile Duct Neoplasms
Pancreatic Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Biliary Tract Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Site
Pancreatic Diseases

ClinicalTrials.gov processed this record on November 25, 2014