UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of metallic stents with anti-reflux property in lower bile duct occlusion
Title of the study (Brief title)	Effectiveness of anti-reflux metallic stents in lower bile duct occlusion
Region	Japan

Condition
Condition	lower bile duct occlusion due to malignant disorders
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effectiveness of metallic bile duct stents with anti-reflux property
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	period until occlusion of the placed stent
Key secondary outcomes	complications related to the stents, dislodgement of the stents, success rate of jaundice relief

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Wallflex stent
Interventions/Control_2	Biliary Long-Covered ComVi 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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	cases with malignant occlusion of the lower bile duct
Key exclusion criteria	cases in which endoscopic approach to the bile duct is impossible, cases that refuse to provide signed informed consent form
Target sample size	70

Research contact person
Name of lead principal investigator	Nobuyuki Matsuhashi
Organization	NTT Medical Center Tokyo
Division name	Dept of Gastroenterology
Address	5-9-22 Higashi-gotanda, Shinagawa-ku
TEL	0334486245
Email	nmatuha-tky@umin.ac.jp

Public contact
Name of contact person	Toshio Fujisawa
Organization	NTT Medical Center Tokyo
Division name	Dept of Gastroenterology
Address	5-9-22 Higashi-gotanda, Shinagawa-ku
TEL	0334486245
Homepage URL
Email	tossshy@ybb.ne.jp

Sponsor
Institute	NTT Medical Center Tokyo
Institute
Department

Funding Source
Organization	NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization	Profit organization
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	2014 Year 08 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 03 Month 01 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 08 Month 12 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015788