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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016513
Receipt No. R000019176
Scientific Title Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Date of disclosure of the study information 2015/02/11
Last modified on 2015/02/11

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Basic information
Public title Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Acronym Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title:Acronym Usefulness in double bare type metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Region
Japan

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

Objectives
Narrative objectives1 Efficacy and safety of double bare type metallic stent of uncovered metallic stent and covered metallic stent for distal biliary tract obstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes stent patency
obstruction rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Single blind -investigator(s) and 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 Uncovered metallic stent
Interventions/Control_2 Covered metallic 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. Having lower part biliary tract stenosis in the unresectable malignancy.
2. Age is a patient 20 years or older at the agreement acquisition.
3.Patients who understand and are willing to give a written informed consent about participation
Key exclusion criteria 1.Performance Status (PS)4.
2.The patient who has serious disease.
3.The pacient with anticoagulant therapy.
4.The woman becomes pregnant or might be pregnant.
5.The patient who has bile duct stenosis in the liver from a hepatic portal region.
6.Approach from papilla is difficult.
7.Insertion of the endoscope is impossible.
8.Not to include the case that removed duodenal confinement by patient.
9.The patient was judged the physician to be inappropriate.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi IRISAWA
Organization Fukushima Medical University Aizu Medical Center
Division name gastroenterology
Zip code
Address 21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL (0242)75-2100
Email irisawa@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo IGARASHI
Organization Fukushima Medical University Aizu Medical Center
Division name gastroenterology
Zip code
Address 21-2 Maeda,Tanisawa,Kawahigashi, Aizuwakamatsu City
TEL (0242)75-2100
Homepage URL
Email ryo-i@fmu.ac.jp

Sponsor
Institute Fukushima Medical University Aizu Medical Center
Institute
Department

Funding Source
Organization Fukushima Medical University Aizu Medical Center
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 02 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Open public recruiting
Date of protocol fixation
2015 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 02 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 02 Month 11 Day
Last modified on
2015 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019176

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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