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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000037411 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Post-pancreaticoduodenectomy | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
Institute | Department of Hepatobiliary-Pancreatic Surgery, Juntendo University School of Medicine |
Institute | |
Department |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | score of objective structured assessment of technical skill |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042624 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |