UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053932 |
|---|---|
| Receipt number | R000061558 |
| Scientific Title | Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/03/21 15:28:48 |
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Basic information
Public title
Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures
Acronym
Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures
Scientific Title
Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures
Scientific Title:Acronym
Randomized comparative study comparing stent patency rates with different plastic stent compositions for benign bile duct strictures
Region
| Japan |
Condition
Condition
Benign biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether differences in the composition of plastic stents used for benign biliary strictures affect the stent patency rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stent patency rate at 3 months
Key secondary outcomes
Reason for stent dysfunction, endoscopic findings of removal stent, technical success rate, adverse event, primary disease, procedure time
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
polyurethane plastic stent group and polyurethane/PTFE plastic stent group
Interventions/Control_2
stent deployment during 3 months
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
1. distal biliary stricture
2. >18yo
Key exclusion criteria
1. Total gastrectomy
2. combined with percutaneous transhepatic biliary drainage
3. Hilar stricture
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ogura |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Endoscopy Center
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
oguratakeshi0411@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Okuda |
Organization
Osaka Medical and Pharmaceutical University
Division name
2nd Department of Internal Medicine
Zip code
569-8686
Address
2-7 Daigakuchou, Takatsukishi, Osaka
TEL
072-683-1221
Homepage URL
ubuntu_koromo@yahoo.co.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University,
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University,
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Osaka Medical and Pharmaceutical University
Address
2-7 Daigakuchou, Takatsukishi, Osaka
Tel
072-683-1221
rinri@ompu.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
| 2024 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 01 | 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
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061558
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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