UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043526 |
|---|---|
| Receipt number | R000049703 |
| Scientific Title | Clinical study on the results of medical examination and treatment in the biliary pancreas diseases. |
| Date of disclosure of the study information | 2021/03/06 |
| Last modified on | 2024/02/05 14:24:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Clinical study on the results of medical examination and treatment in the biliary pancreas diseases.
Grade survey
Acronym
Clinical study on the results of medical examination and treatment in the biliary pancreas diseases.
Grade survey
Scientific Title
Clinical study on the results of medical examination and treatment in the biliary pancreas diseases.
Scientific Title:Acronym
Clinical study on the results of medical examination and treatment in the biliary pancreas diseases.
Region
| Japan |
Condition
Condition
Biliary pancreatic disease
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Abdominal ultrasonography, endoscopy, treatment, and other commonly performed medical treatments such as anticancer drug treatment as examination treatment of the biliary and pancreatic region in the hepatobiliary and pancreatic diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the characteristics of biliary pancreatic diseases.
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
1. For those who can show their own free will and their family's free will with sufficient understanding.
2. It was set in consideration of the age at which the disease is likely to occur and the patient's ability to express intention.
3, Set for accurate effectiveness evaluation.
Key exclusion criteria
1. Patients who are refused to participate in the study by themselves or their families
2. In addition, patients who are judged to be inappropriate by the principal investigator and the research coordinator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita health university
Division name
Department of Gastroenterology and Gastroenterological Oncology, Fujita Health University.
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazunori |
| Middle name | |
| Last name | Nakaoka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Gastroenterological Oncology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
0562932324
Homepage URL
knakaoka@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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
0562932324
knakaoka@fujita-hu.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
| 2021 | Year | 03 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Fujita Health University.
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2024 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049703
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
