UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter, prospective, randomised study of "covered" versus "uncovered" stents for the management of distal malignant biliary obstruction
Title of the study (Brief title)	A multicenter randomized controlled trial of metallic stent for unresectable distal malignant biliary obstruction
Region	Japan

Condition
Condition	Malignant biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare the patency and safety of Fully-covered versus Uncovered WallFlex stent for unresectable distal malignant biliary obstruction.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Time to stent dysfunction
Key secondary outcomes	Effectiveness 1) Stent patency period 2) Survival period 3) Event free survival 4) Stent patency period after reintervention 5) Time to stent dysfunction after reintervention 6) Cost effectiveness Safety 1) Early complications 2) Late complications 3) Technical success rate 4) Removability of the stent 5) Removability of the second stent

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	WallFlex Fully-covered biliary stent
Interventions/Control_2	WallFlex Uncovered biliary stent
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with unresectable distal malignant biliary obstruction, not limited to primary disease. 2) Patients with predictable prognosis of more than 4 months. 3) Patients with written informed consent. 4) Patients with performance status 0-3.
Key exclusion criteria	1) Patients with massive ascites. 2) Patients with severely impaired organ function. 3) Patients for whom endoscopic biliary drainage is difficult. 4) Patients with duodenal obstruction. 5) Patients whose antithrombotic drugs cannot be stopped. 6) Patients considered ineligible for this study.
Target sample size	200

Research contact person
Name of lead principal investigator	Tsutomu Chiba
Organization	Faculty of Medicine, Kyoto University
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-4319
Email

Public contact
Name of contact person	Akira Kurita
Organization	Faculty of Medicine, Kyoto University
Division name	Department of Gastroenterology and Hepatology
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL	075-751-4319
Homepage URL
Email	akurita@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Kyoto University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Kyoto University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2012 Year 09 Month 01 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 12 Month 20 Day
Anticipated trial start date	2012 Year 11 Month 01 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 28 Day
Date trial data considered complete	2018 Year 03 Month 31 Day
Date analysis concluded	2018 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 08 Month 01 Day
Last modified on	2017 Year 11 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010088