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Recruitment status Completed
Unique ID issued by UMIN UMIN000013291
Receipt No. R000015464
Scientific Title Efficacy and safety of inside stent in patients with biliary stricture: a prospective multicenter study
Date of disclosure of the study information 2014/03/10
Last modified on 2019/09/02

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Isayama
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Gastroenterology
Zip code
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
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
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

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
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
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/ctr_e/ctr_view.cgi?recptno=R000015464


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