UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	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	Preinitiation
Date of protocol fixation	2019 Year 04 Month 18 Day
Date of IRB
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	2019 Year 07 Month 18 Day

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

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