UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of inside stent in patients with biliary stricture: a prospective multicenter study
Acronym	Multicenter Evolving Inside Stent Registry (MEISteR)
Scientific Title	Efficacy and safety of inside stent in patients with biliary stricture: a prospective multicenter study
Scientific Title:Acronym	Multicenter Evolving Inside Stent Registry (MEISteR)
Region	Japan

Condition
Condition	benign and malignant biliary stricture
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of inside stent for benign and malignant biliary stricture.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Stent patency period 2) Time to stent dysfunction
Key secondary outcomes	1) Technical success rate 2) Complication rate 3) resolution rate of benign biliary strictures

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	Inside stent
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with benign or malignant biliary stricture. 2) Patients with written informed consent.
Key exclusion criteria	1) Patients with less than 2cm distance between the papilla of Vater and biliary stricture. 2) Patients with tumor invasion to the papilla of Vater. 3) Patients with acute pancreatitis. 4) Patients with pregnancy or possible pregnancy. 5) Patients considered ineligible by the attending physician.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Isayama
Organization	Graduate School of Medicine, The University of Tokyo
Division name	Department of Gastroenterology
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	isayama-tky@umin.ac.jp

Public contact
Name of contact person	1st name Hirofumi Middle name Last name Kogure
Organization	Secretariat of Inside Stent Study Group
Division name	Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo
Zip code	113-8655
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Homepage URL
Email	kogureh-tky@umin.ac.jp

Sponsor
Institute	Inside Stent Study Group
Institute
Department

Funding Source
Organization	Gadelius Medical K.K.
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	Office for Human Research Studies (OHRS)
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.ac.jp

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	1. 東京大学医学部附属病院（東京都） 2. 北海道大学病院（北海道） 3. 札幌医科大学附属病院（北海道） 4. 手稲渓仁会病院（北海道） 5. 横浜市立大学附属市民総合医療センター（神奈川県） 6. 大阪赤十字病院（大阪府） 7. 岡山大学病院（岡山県） 8. JA尾道総合病院（広島県） 9. 久留米大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 03 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	134
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	2014 Year 02 Month 25 Day
Date of IRB	2014 Year 02 Month 24 Day
Anticipated trial start date	2014 Year 03 Month 10 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 02 Month 26 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015464