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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

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.DPrincipal 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.DPrincipal Investigator
  Onomichi
 Onomichi General Hospital
 Hanada Keiji, PH.D Ph: +81-848-24-8811
  Email: Kh-ajpbd@nifty.com
 Hanada Keiji, PH.DPrincipal Investigator
  Sapporo
 Teine-Keijinkai Hospital
 Maguchi Hiroyuki, PH.D Ph: +81-11-681-8111
  Email: maguchi@tb3.so-net.ne.jp
 Maguchi Hiroyuki, PH.DPrincipal 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.DPrincipal 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.DPrincipal 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.DPrincipal 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.DPrincipal 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.DPrincipal 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.DPrincipal 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.DPrincipal Investigator
  Incheon
 Inha University Hospital
 Don Haeng Lee, PH.D Ph: +82-32-890-2548
  Email: idh@inha.ac.kr
 Don Haeng Lee, PH.DPrincipal Investigator
  Seoul
 Gangnam Severance Hospital
 Dong Ki Lee, Ph.D Ph: +82-11-9057-8804
  Email: dklee@yuhs.ac
 Dong Ki Lee, PH.DPrincipal Investigator
  Suwon
 Ajou University Hospital
 Jin Hong Kim, PH.D Ph: +82-011-280-3131
  Email: jinhkim@ajou.ac.kr
 Jin Hong Kim, PH.DPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01041612
ClinicalTrials.gov processed this data on October 17, 2013

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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