Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
Trial Sites
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase IV | Treatment | Active | 18 and over | Other | RaMM-BO 2.0 NCT01041612 |
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.
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
Trial Lead Organizations/Sponsors
Taewoong-Medical Company, Limited
| Dong Ki Lee, PH.D |  | Principal Investigator |
Trial Sites
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| Japan | |||
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| Gifu | |||
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| Gifu University Graduate School of Medicine | |||
| Yasuda Ichiro, PH.D | Ph: +81-90-8072-4480 | ||
| Email: yasudaic@aol.com | |||
| Yasuda Ichiro, PH.D | Principal Investigator | ||
| Onomichi | |||
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| Onomichi General Hospital | |||
| Hanada Keiji, PH.D | Ph: +81-848-24-8811 | ||
| Email: Kh-ajpbd@nifty.com | |||
| Hanada Keiji, PH.D | Principal Investigator | ||
| Sapporo | |||
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| Teine-Keijinkai Hospital | |||
| Maguchi Hiroyuki, PH.D | Ph: +81-11-681-8111 | ||
| Email: maguchi@tb3.so-net.ne.jp | |||
| Maguchi Hiroyuki, PH.D | Principal Investigator | ||
| Tokyo | |||
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| Toho University School of Medicine | |||
| Maetani Iruru, PH.D | Ph: +81-3-3468-1251 | ||
| Email: mtnir50637@med.toho-u.ac.jp | |||
| Maetani Iruru, PH.D | Principal Investigator | ||
| Tokyo Medical University Hachioji Medical Center | |||
| Itoi Takao, PH.D | Ph: +81-90-8774-1212 | ||
| Email: itoi@tokyo-med.ac.jp | |||
| Itoi Takao, PH.D | Principal Investigator | ||
| University of Tokyo Hospital | |||
| Isayama Hiroyuki, PH.D | Ph: +81 90-5318-0775 | ||
| Email: isayama-2im@h.u-tokyo.ac.jp | |||
| Isayama Hiroyuki, PH.D | Principal Investigator | ||
| Ube | |||
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| Yamaguchi University Graduate School of Medicine | |||
| Ryozawa Shomei, PH.D | Ph: +81-90-5086-2902 | ||
| Email: ryozawa@yamaguchi-u.ac.jp | |||
| Ryozawa Shomei, PH.D | Principal Investigator | ||
| Republic of Korea | |||
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| Bucheon | |||
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| Soonchunhyang University Bucheon Hospital | |||
| Jong Ho Moon, PH.D | Ph: +82-11-9715-3543 | ||
| Email: jhmoon@schbc.ac.kr | |||
| Jong Ho Moon, PH.D | Principal Investigator | ||
| Cheonan | |||
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| Soonchunhyang University Bucheon Hospital | |||
| Sang Heum Park, PH.D | Ph: +82-41-570-3678 | ||
| Email: ppargsh@sch.ac.kr | |||
| Sang Heum Park, PH.D | Principal Investigator | ||
| Daegu | |||
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| Daegu Catholic University Hospital | |||
| Ho Gak Kim, PH.D | Ph: +82-10-3503-4659 | ||
| Email: hgkim@cu.ac.kr | |||
| Ho Gak Kim, PH.D | Principal Investigator | ||
| Incheon | |||
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| Inha University Hospital | |||
| Don Haeng Lee, PH.D | Ph: +82-32-890-2548 | ||
| Email: idh@inha.ac.kr | |||
| Don Haeng Lee, PH.D | Principal Investigator | ||
| Seoul | |||
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| Gangnam Severance Hospital | |||
| Dong Ki Lee, Ph.D | Ph: +82-11-9057-8804 | ||
| Email: dklee@yuhs.ac | |||
| Dong Ki Lee, PH.D | Principal Investigator | ||
| Suwon | |||
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| Ajou University Hospital | |||
| Jin Hong Kim, PH.D | Ph: +82-011-280-3131 | ||
| Email: jinhkim@ajou.ac.kr | |||
| Jin Hong Kim, PH.D | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01041612
Information obtained from ClinicalTrials.gov on November 20, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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