UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017918 |
|---|---|
| Receipt number | R000020769 |
| Scientific Title | Retrospective comparative study of endoscopic papillary large balloon dilation with or without previous endoscopic sphincterotomy for common bile duct stone |
| Date of disclosure of the study information | 2015/06/16 |
| Last modified on | 2022/12/19 11:41:19 |
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Basic information
Public title
Retrospective comparative study of endoscopic papillary large balloon dilation with or without previous endoscopic sphincterotomy for common bile duct stone
Acronym
Efficacy and safety of EPLBD with or without EST for common bile duct stone
Scientific Title
Retrospective comparative study of endoscopic papillary large balloon dilation with or without previous endoscopic sphincterotomy for common bile duct stone
Scientific Title:Acronym
Efficacy and safety of EPLBD with or without EST for common bile duct stone
Region
| Japan |
Condition
Condition
Common bile duct stone
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the retrospectively efficacy and safety of EPLBD with or without EST for common bile duct stone.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conclusive complete stone removal of bile duct stone
Key secondary outcomes
complication
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
more than 10mm common bile duct stone
Multiple common bile duct stone
Key exclusion criteria
Concomitant pancreatic or biliary malignancy
Pancreatitis
Surgically altered anatomy which except Billroth-I
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Iwashita |
Organization
Gifu University Hospital
Division name
First Department of internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
+81-58-230-6308
takuji@w7.dion.ne.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Okuno |
Organization
Gifu University Hospital
Division name
First Department of internal Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu city, Gifu
TEL
+81-58-230-6308
Homepage URL
mkobdkl@yahoo.co.jp
Sponsor or person
Institute
Gifu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu University Hospital
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
Gifu University Hospital First Department of internal Medicine
Address
1-1 Yanagido, Gifu city, Gifu
Tel
+81-58-230-6308
mkobdkl@yahoo.co.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
| 2015 | Year | 06 | Month | 16 | 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
| 2015 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 01 | Month | 01 | Day |
Other
Other related information
We can predict that prior EST might be not essential for performing EPLBD.
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020769
