UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034427 |
|---|---|
| Receipt number | 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 00:29:57 |
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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
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
sho-takahashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037006
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
