UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroyuki Isayama
Organization	Juntendo University School of Medicine
Division name	Gastroenterology
Address	Hongo3-1-3, Bunkyo, Tokyo, Japan
TEL	03-3813-3111
Email	sho-takahashi@juntendo.ac.jp

Public contact
Name of contact person	Sho Takahashi
Organization	Juntendo University School of Medicine
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 23 Day
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

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Publication of results	Unpublished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