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

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 Intervention Model: Single Group Assignment Masking: Single Blind (Participant) 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:

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer

U.S. FDA Resources

Further study details as provided by Jong Taek, Lee, 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 ]

Secondary Outcome Measures:

Death of patients [ Time Frame: one year ]


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)
Sexes Eligible for Study:	All
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
Individual Participant Data
Plan to Share IPD:	No

Keywords provided by Jong Taek, Lee, 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 May 25, 2017