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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentActive18 and overOtherRaMM-BO 2.0
NCT01041612

Trial Description

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 Contact Information

Trial Lead Organizations/Sponsors

Taewoong-Medical Company, Limited

    Dong Ki Lee, PH.D, Principal Investigator

    Trial Sites

    Japan

    Gifu

    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

    Onomichi General Hospital

    Hanada Keiji, PH.D
    Ph: +81-848-24-8811
    Email: Kh-ajpbd@nifty.com

    Hanada Keiji, PH.D
    Principal Investigator

    Sapporo

    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

    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

    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

    Bucheon

    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

    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

    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

    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

    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

    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 Identifier NCT01041612
    ClinicalTrials.gov processed this data on April 09, 2015

    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.