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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019786
Receipt No. R000022853
Scientific Title Side-by-side placement using partially covered self-expandable metal stent in endoscopic biliary stenting for unresectable malignant hilar biliary stricture
Date of disclosure of the study information 2015/11/15
Last modified on 2017/12/31

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Basic information
Public title Side-by-side placement using partially covered self-expandable metal stent in endoscopic biliary stenting for unresectable malignant hilar biliary stricture
Acronym Side-by-side placement using partially covered self-expandable metal stent for unresectable malignant hilar biliary stricture
Scientific Title Side-by-side placement using partially covered self-expandable metal stent in endoscopic biliary stenting for unresectable malignant hilar biliary stricture
Scientific Title:Acronym Side-by-side placement using partially covered self-expandable metal stent for unresectable malignant hilar biliary stricture
Region
Japan

Condition
Condition Unresectable malignant hilar biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility and utility of side-by-side placement using partially covered self-expandable metal stent in endoscopic biliary metal stenting for unresectable malignant hilar biliary stricture.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stent patency period
Key secondary outcomes Re-intervention rate
Adverse events rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Partially covered self-expandable metal stent
Between July 2013 and June 2015
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Unresectable malignant hilar biliary stricture
Key exclusion criteria Resectable malignant hilar biliary stricture
Inability to obtain informed consent
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Email k.kitamura@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuya Kitamura
Organization Showa University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL 03-3784-8535
Homepage URL
Email k.kitamura@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 14 Day
Last modified on
2017 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022853

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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