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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jong Taek, Lee, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01041612
First received: December 28, 2009
Last updated: October 19, 2016
Last verified: October 2016
  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 ]

Enrollment: 120
Study Start Date: January 2010
Study Completion Date: September 2012
Primary Completion Date: September 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
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
Gifu, Japan
Onomichi General Hospital
Onomichi, Japan
Teine-Keijinkai Hospital
Sapporo, Japan
The University of Tokyo
Tokyo, Japan
Toho University
Tokyo, Japan
Tokyo Medical University
Tokyo, Japan
Yamaguchi University
Ube, Japan
Korea, Republic of
Soon Chun Hyang University School of Medicine
Bucheon, Korea, Republic of
Soon Chun Hyang University School of Medicine
Cheonan, Korea, Republic of
Catholic University of Daegu School of Medicine
Daegu, Korea, Republic of
Inha University School of Medicine
Incheon, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of, 135-720
Ajou University School of Medicine
Suwon, Korea, Republic of
Sponsors and Collaborators
Taewoong Medical Co., Ltd.
Investigators
Principal Investigator: Dong Ki Lee, PH.D Gangnam Severance Hospital
  More Information

Publications:
Jung Nam Cho, Jimin Han, Ho Gak Kim, IM Hee Shin, Sang Heum Park, Jong Ho Moon, Jin Hong Kim, Don Haeng Lee, Iruru Maetani, Hiroyuki Maguchi, Keiji Hanada, Ichiro Yasuda, Takao Itoi, Hiroyuki Isayama, Dongki Lee. Prospective Randomized Trial Comparing Covered Metal Stent Placed Above and Across the Sphincter of Oddi in Malignant Biliary Obstruction. Gastrointestinal Endoscopy 77(58): AB139-AB140, 2013

Responsible Party: Jong Taek, Lee, General manager, Taewoong Medical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01041612     History of Changes
Other Study ID Numbers: RaMM-BO 2.0 
Study First Received: December 28, 2009
Last Updated: October 19, 2016
Health Authority: Korea: Institutional Review Board
Japan: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Pancreatic Neoplasms
Bile Duct 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 December 09, 2016