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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034427
Receipt No. R000037006
Scientific Title Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research
Date of disclosure of the study information 2018/10/10
Last modified on 2018/10/10

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Basic information
Public title Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research
Acronym M-FED Study
Scientific Title Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research
Scientific Title:Acronym M-FED Study
Region
Japan

Condition
Condition Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study): A Multi-center Prospective Randomized Controlled Trial Research
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Multi-Hole Self-expandable Metal Stent (MHSEMS) versus Fully-covered Self-Expandable Metal Stent (FCSEMS) for Unresectable Malignant Distal Biliary Obstruction (M-FED Study)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A migration rate compared with a conventional stent (FCSEMS) of a new stent (MHSEMS)
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Inserting Multi-Hole covered Self-expandable Metal Stent(MHSEMS) for the patient who has unresectable malignant distal biliary obstruction.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patient with Unresectable Malignant Distal Biliary Obstruction
Key exclusion criteria 1.Pregnancy
2.Contraindications for ERCP
3.Hilar stricture identified during cholangiogram
4.Failed ERCP
5.Subsequent investigations diagnose benign biliary strictures
Target sample size 78

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Isayama
Organization Juntendo University School of Medicine
Division name Gastroenterology
Zip code
Address Hongo3-1-3, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Email sho-takahashi@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sho Takahashi
Organization Juntendo University School of Medicine
Division name Gastroenterology
Zip code
Address Hongo3-1-3, Bunkyo, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email sho-takahashi@juntendo.ac.jp

Sponsor
Institute Juntendo University School of Medicine
Institute
Department

Funding Source
Organization MI Tech
Organization
Division
Category of Funding Organization Profit organization
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
2018 Year 10 Month 10 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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 23 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
2018 Year 10 Month 10 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037006

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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