UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035720 |
|---|---|
| Receipt number | R000040692 |
| Scientific Title | Analysis of risk factors for the recurrence of bile duct stones in patients treated with endoscopy |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/01/30 19:06:46 |
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Basic information
Public title
Analysis of risk factors for the recurrence of bile duct stones in patients treated with endoscopy
Acronym
Analysis of risk factors for the recurrence of bile duct stones
Scientific Title
Analysis of risk factors for the recurrence of bile duct stones in patients treated with endoscopy
Scientific Title:Acronym
Analysis of risk factors for the recurrence of 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 identify significant risk factors for the recurrence of bile duct stones
Basic objectives2
Others
Basic objectives -Others
To identify patients' risk factors for the recurrence of bile duct stones
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of recurrence of common bile duct stones
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
The patients who were hospitalized for common bile duct stones
Key exclusion criteria
Patients who did not undergo endoscopic removal of stones
Patients who had concomitant pancreaticobiliary malignancy
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiko Satoh |
Organization
South Miyagi Medical Center
Division name
Department of Gastroenterology
Zip code
Address
38-1 Aza-Nishi, Ohgawara, Miyagi 989-1253, Japan
TEL
+81-224-51-5500
asato@bf7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Satoh |
Organization
South Miyagi Medical Center
Division name
Department of Gastroenterology
Zip code
Address
38-1 Aza-Nishi, Ohgawara, Miyagi 989-1253, Japan
TEL
+81-224-51-5500
Homepage URL
asato@bf7.so-net.ne.jp
Sponsor or person
Institute
South Miyagi Medical Center
Institute
Department
Personal name
Funding Source
Organization
South Miyagi Medical Center
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
Address
Tel
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
| 2019 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Saline solution irrigation with a specially designed biliary catheter reduces the recurrence of common bile duct stone
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
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational study
Management information
Registered date
| 2019 | Year | 01 | Month | 30 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040692
