UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013291 |
|---|---|
| Receipt number | 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 12:46:26 |
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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
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
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
kogureh-tky@umin.ac.jp
Sponsor or person
Institute
Inside Stent Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015464
