UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056409 |
|---|---|
| Receipt number | R000062174 |
| Scientific Title | Clinical outcomes comparing wait-and-see and early intervention strategies for asymptomatic bile duct stones. |
| Date of disclosure of the study information | 2024/12/10 |
| Last modified on | 2024/12/14 10:56:51 |
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Basic information
Public title
Clinical outcomes comparing wait-and-see and early intervention strategies for asymptomatic bile duct stones.
Acronym
Silent study
Scientific Title
Clinical outcomes comparing wait-and-see and early intervention strategies for asymptomatic bile duct stones.
Scientific Title:Acronym
Silent study
Region
| Japan |
Condition
Condition
asymptomatic bile duct stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare clinical outcomes of wait-and-see and endoscopic removal for asymptomatic bile duct stones.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the composite rate of adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are diagnosed to have bile duct stones.
2) Patients without symptoms (e.g., abdominal pain or fever) or elevated liver enzyme.
3) Patients who are 18 years old or more.
Key exclusion criteria
1) Patients with previous history of biliary drainage.
2) Patients with previous endoscopic papillectomy.
3) Patients with previous biliary surgery.
4) Patients with history of cholangitis, cholecystitis, or liver abscess.
5) Patients with previous history of cholestasis.
6) Patients with biliary stricture.
7) Patients with hepatolithiasis.
8) Patients with surgically-altered anatomy (Billroth-II or Roux-en-Y reconstruction).
9) Patients who are undergoing surgical bile duct extraction with cholecystectomy.
10) Patients under 18 years old or with pregnancy.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Yasuda |
Organization
Toyama University Hospital
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugiya, Toyama, Toyama, Japan
TEL
076-434-7301
yasudaic@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Hayashi |
Organization
University of Toyama
Division name
Third Department of Internal Medicine
Zip code
930-0194
Address
2630 Sugiya, Toyama, Toyama, Japan
TEL
076-434-7301
Homepage URL
hayashi@med.u-toyama.ac.jp
Sponsor or person
Institute
Toyama 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
Ethics committee, University of Toyama
Address
2630 Sugiya, Toyama, Toyama, Japan
Tel
076-415-8857
rinri@adm.u-toyama.ac.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 | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2030 | Year | 03 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062174
