UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055951 |
|---|---|
| Receipt number | R000063937 |
| Scientific Title | A Retrospective Study on Treatment Outcomes in Asymptomatic Common Bile Duct Stones |
| Date of disclosure of the study information | 2024/11/01 |
| Last modified on | 2024/10/25 15:26:03 |
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Basic information
Public title
Retrospective Study on the Risk of Post-ERCP Pancreatitis in Patients with Asymptomatic Common Bile Duct Stones and Native Papilla
Acronym
Retrospective Study on the Risk of Post-ERCP Pancreatitis in Patients with Asymptomatic Common Bile Duct Stones and Native Papilla
Scientific Title
A Retrospective Study on Treatment Outcomes in Asymptomatic Common Bile Duct Stones
Scientific Title:Acronym
A Retrospective Study on Treatment Outcomes in Asymptomatic Common Bile Duct Stones
Region
| Japan |
Condition
Condition
Cases of Endoscopic Treatment for Common Bile Duct Stones with a Native Papilla
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of endoscopic treatment for asymptomatic common bile duct stones
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of post-ERCP pancreatitis
Key secondary outcomes
Technical and clinical success rates of endoscopic procedure for choledocholithiasis
Adverse events of endoscopic procedures
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of Endoscopic Treatment for Common Bile Duct Stones with a Native Papilla
Key exclusion criteria
The patients who are otherwise judged by the investigator to be ineligible to participate in the study.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Kataoka |
Organization
Matsunami general hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
185-1 Kasamatsu-cho, Hashima-gun, Gifu
TEL
058-388-0111
a9mb1039@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Kataoka |
Organization
Matsunami general hospital
Division name
Department of Gastroenterology
Zip code
501-6062
Address
185-1 Kasamatsu-cho, Hashima-gun, Gifu
TEL
058-388-0111
Homepage URL
a9mb1039@yahoo.co.jp
Sponsor or person
Institute
Matsunami general hospital
Institute
Department
Personal name
Funding Source
Organization
Matsunami general hospital
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
Matsunami general hospital
Address
185-1 Kasamatsu-cho, Hashima-gun, Gifu
Tel
058-388-0111
a9mb1039@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
| 2024 | Year | 11 | Month | 01 | 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 | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 10 | Month | 25 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063937
