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

Pancreatic Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041612
• Other study ID #: RaMM-BO 2.0
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2009
• Last updated: October 19, 2016
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: October 2016
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardJapan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bile Duct Neoplasms
• Cancer of Bile Duct
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
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
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	Ajou University School of Medicine	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Countries where clinical trial is conducted

Japan,  Korea, Republic of, 

References & Publications (1)

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 Cov

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange		one year	Yes
Secondary	Death of patients		one year	Yes