UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021995 |
|---|---|
| Receipt number | R000025340 |
| Scientific Title | Long-term outcomes in patients with gallstones detected by mass screening |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2017/10/21 09:28:40 |
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Basic information
Public title
Long-term outcomes in patients with gallstones detected by mass screening
Acronym
Long-term outcomes of gallstones
Scientific Title
Long-term outcomes in patients with gallstones detected by mass screening
Scientific Title:Acronym
Long-term outcomes of gallstones
Region
| Japan |
Condition
Condition
gallstones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate outcomes in patients with gallstones detected by mass survey
Basic objectives2
Others
Basic objectives -Others
To evaluate clinical features of those requiring surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare individuals requiring or not requiring cholecystectomy as to clinical features
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
patients with gallstones detected by mass survey
Key exclusion criteria
Persons who do not agree with participation in the study
Target sample size
720
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Inui |
Organization
Second Teaching Hospital, Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
3-6-10, Otobashi, Nakagawa-ku, Nagoya 454-8509, Japan
TEL
052-321-8171
kinui@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Inui |
Organization
Second Teaching Hospital, Fujita Health University
Division name
Department of Gastroenterology
Zip code
Address
3-6-10, Otobashi, Nakagawa-ku, Nagoya 454-8509, Japan
TEL
052-321-8171
Homepage URL
http://www.fujita-hu.ac.jp/HOSPITAL2/
kinui@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
| 2016 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Among persons with gallstones detected by
screening, men who drank, had abdominal symptoms, and
showed gallbladder wall thickening or adenomyomatosis
were more likely to require surgery within 4 years.
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
| 2016 | Year | 04 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 28 | Day |
Date analysis concluded
| 2016 | Year | 10 | Month | 20 | Day |
Other
Other related information
presented at American Gastroenterology Association in 2015. published on the expert journal, JHBPS in Oct. 2016.
Management information
Registered date
| 2016 | Year | 04 | Month | 20 | Day |
Last modified on
| 2017 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025340
| 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 |
