UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037411 |
|---|---|
| Receipt number | R000042624 |
| Scientific Title | Prospective study on the training effect on the reconstruction technique in the pancreatoduodenectomy (pancreato-jejunosutomy and bilio-jujunostomy) using swine and bio tissue. |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/01/19 12:51:17 |
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Basic information
Public title
Prospective study on the training effect on the reconstruction technique in the pancreatoduodenectomy (pancreato-jejunosutomy and bilio-jujunostomy) using swine and bio tissue.
Acronym
Prospective study on the training effect on the reconstruction technique in the pancreatoduodenectomy
Scientific Title
Prospective study on the training effect on the reconstruction technique in the pancreatoduodenectomy (pancreato-jejunosutomy and bilio-jujunostomy) using swine and bio tissue.
Scientific Title:Acronym
Prospective study on the training effect on the reconstruction technique in the pancreatoduodenectomy
Region
| Japan |
Condition
Condition
Post-pancreaticoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the the training effect on the reconstruction technique in the pancreatoduodenectomy (pancreato-jejunosutomy and bilio-jujunostomy) using swine and bio tissue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the scores according to objective structured assessment of technical skill after five trainings
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hepatobiliary trainee belonging to the Department of Hepato-biliary-pancreatic surgery, Juntendo University School of Medicine
Key exclusion criteria
Disagreemet with the trial participation
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Saiura |
Organization
Juntendo University School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
0338183111
a-saiura@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ryuji |
| Middle name | |
| Last name | Yoshioka |
Organization
Juntendo University School of Medicine
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
1138421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL
0338183111
Homepage URL
r-yoshioka@juntendo.ac.jp
Sponsor or person
Institute
Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine
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
Juntendo University School of Medicine
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
Tel
0338183111
rinri@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 01 | 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
8
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
Completed
Date of protocol fixation
| 2019 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
score of objective structured assessment of technical skill
Management information
Registered date
| 2019 | Year | 07 | Month | 18 | Day |
Last modified on
| 2021 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042624
| 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 |
