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
Recruitment status was Recruiting
Sponsor:
Taewoong Medical Co., Ltd.
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
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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 (Adult, Senior) |
| 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
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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
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
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016