UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044290 |
|---|---|
| Receipt number | R000050589 |
| Scientific Title | retrospective study about the association between incision length of EST and recurrence of common bile duct stones |
| Date of disclosure of the study information | 2021/05/21 |
| Last modified on | 2022/05/22 17:55:49 |
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Basic information
Public title
study about the association between incision length of EST and recurrence of common bile duct stones
Acronym
study about the association between incision length of EST and recurrence of common bile duct stones
Scientific Title
retrospective study about the association between incision length of EST and recurrence of common bile duct stones
Scientific Title:Acronym
retrospective study about the association between incision length of EST and recurrence of common bile duct stones
Region
| Japan |
Condition
Condition
Common bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the size of the EST and DBCS recurrence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between the size of the EST and CBDS recurrence rate
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent the elective endoscopic treatment for CBDS in Dokkyo Medical University Hospital between January 2013 and December 2017
Key exclusion criteria
(1)patients with previous papillary dilation or sphincterotomy, (2)patients with reconstruction of intestinal tract, (3)patients with benign or malignant biliary strictures, (4)cases with biliary stenting, (5)cases with incomplete CBDS clearance, (6)cases with endoscopic papillary balloon dilation, and (7)cases without EST
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Irisawa |
Organization
Dokkyo Medical University
Division name
gastroenterology
Zip code
3210207
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
TEL
0282872147
irisawa@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yoichi |
| Middle name | |
| Last name | Takimoto |
Organization
Dokkyo Medical University
Division name
gastroenterology
Zip code
3210207
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
TEL
0282872147
Homepage URL
takimoto.yo1@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-cho, Shimotsuga-gun,Tochigi-ken
Tel
0282872147
shonai_hp@dokkyomed.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R-45-6J
Org. issuing International ID_1
Dokkyo Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 21 | 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
811
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
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective cohort study conducted in Dokkyo Medical University Hospital. All medical records during January 2013 and December 2020 were reviewed retrospectively.
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2022 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
