UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049209 |
|---|---|
| Receipt number | R000056049 |
| Scientific Title | Endoscopic papillary balloon dilation can be safely performed in patients with dual antiplatelet therapy: A pilot study |
| Date of disclosure of the study information | 2022/10/18 |
| Last modified on | 2022/10/13 17:17:19 |
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Basic information
Public title
Endoscopic papillary balloon dilation can be safely performed in patients with dual antiplatelet therapy: A pilot study
Acronym
Endoscopic papillary balloon dilation is safe for patients with dual antiplatelet therapy
Scientific Title
Endoscopic papillary balloon dilation can be safely performed in patients with dual antiplatelet therapy: A pilot study
Scientific Title:Acronym
Endoscopic papillary balloon dilation is safe for patients with dual antiplatelet therapy
Region
| Japan |
Condition
Condition
common bile duct stone
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
investigation for safe
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bleeding
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
with antiplatelet thrapy
Key exclusion criteria
without antiplatelet thrapy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakue |
| Middle name | |
| Last name | Masuda |
Organization
Shonan Kamakura General Hospital
Division name
Gastrointestinal Medicine Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
sakue3939@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sakue |
| Middle name | |
| Last name | Masuda |
Organization
Shonan Kamakura General Hospital
Division name
Gastrointestinal Medicine Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura, Kanagawa
TEL
0467-46-1717
Homepage URL
sakue3939@yahoo.co.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
mirai-iryo
Address
1-7-8 Kojimachi, Chiyoda, Tokyo
Tel
03-3263-4801
tajima@mirai-iryo.com
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
| 2022 | Year | 10 | Month | 18 | 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
31
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 | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
EPBD for DAPT or SAPT groups.
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056049
