Clinical trial NCT01041612: Comparing Covered Self-expandable Metallic Stent (SEMS) Above/Across the Sphincter of Oddi
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cancer of Bile Duct
Pancreatic Cancer
Keywords: CBD
HBD
cancer of bile duct
pancreatic cancer
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-01-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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

Primary outcomes:
measure: Obstruction of 1st C-SEMS or presence of jaundice at death without stent exchange
timeFrame: one year
Secondary outcomes:
measure: Death of patients
timeFrame: one year
Other outcomes:
Locations:
city: Gifu
country: Japan
facility: Gifu University
city: Onomichi
country: Japan
facility: Onomichi General Hospital
city: Sapporo
country: Japan
facility: Teine-Keijinkai Hospital
city: Tokyo
country: Japan
facility: The University of Tokyo
city: Tokyo
country: Japan
facility: Toho University
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Ube
country: Japan
facility: Yamaguchi University
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University School of Medicine
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University School of Medicine
city: Daegu
country: Korea, Republic of
facility: Catholic University of Daegu School of Medicine
city: Incheon
country: Korea, Republic of
facility: Inha University School of Medicine
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
Study officials:
affiliation: Gangnam Severance Hospital
name: Dong Ki Lee, PH.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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