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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029662
Receipt No. R000033881
Scientific Title Dilation of remnant pancreatic duct after pancreaticoduodenectomy: Clinical implications and risk factors - A prospective Japanese multicenter cohort study
Date of disclosure of the study information 2017/10/22
Last modified on 2019/04/24

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Basic information
Public title Dilation of remnant pancreatic duct after pancreaticoduodenectomy: Clinical implications and risk factors - A prospective Japanese multicenter cohort study
Acronym DAIMONJI-Study
Scientific Title Dilation of remnant pancreatic duct after pancreaticoduodenectomy: Clinical implications and risk factors - A prospective Japanese multicenter cohort study
Scientific Title:Acronym DAIMONJI-Study
Region
Japan

Condition
Condition Periampullary tumors
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to evaluate
the clinical implications and to clarify the risk factor of the dilation of the remnant pancreatic duct a year after pancreaticoduodenectomy in patients with preoperatively non-dilated pancreatic duct who undergo pancreaticoduodenectomy for periampullary tumors
Basic objectives2 Others
Basic objectives -Others The incident rate of the dilation of the remnant pancreatic duct and its' association with pancreatic exo-and endocrine function, nutrition status, development of fatty liver, and the status of diabetes are evaluated.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1) The incident rate of the dilation of the remnant pancreatic duct a year after pancreaticoduodenectomy for periampullary tumors
2) Association between the dilation of the remnant pancreatic duct and pancreatic exo-and endocrine function, nutrition status, development of fatty liver.
Key secondary outcomes 1) Clarification of risk factors of the dilation of the remnant pancreatic duct
2) Time course of the dilation of the remnant pancreatic duct following pancreaticoduodenectomy

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
100 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients aged 20 years or older who are required to perform pancreaticoduodenectomy
2) Patients with non-dilated pancreatic duct in a diameter of less than 3mm
3) Patients who are expected to survive more than 1 year.
4) Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
5)Patients in whom Documented agreement was obtained
Key exclusion criteria 1) Patients who are required to perform concurrent resection of the liver
2) Patients with dilated pancreatic duct in a diameter of 3mm or more
3) Patients who are performed pancreaticoduodenectomy in an emergent setting
4) Patients who cannot use contrast-enhanced CT
5) Patients in whom a doctor judges inappropriate for this study population
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Masato
Middle name
Last name Narita
Organization Kyoto Medical Center
Division name Surgery
Zip code 612-8555
Address 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto city
TEL 0756419161
Email narinari@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Masato
Middle name
Last name Narita
Organization Kyoto Medical Center
Division name Secretariat of DAIMONJI-Study
Zip code 612-8555
Address 1-1 Fukakusamukaihata-cho, Fushimi-ku, Kyoto city
TEL 075-641-9161
Homepage URL
Email narinari@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto Medical Center
Secretariat of DAIMONJI-Study
Institute
Department

Funding Source
Organization Kyoto Medical Center
Secretariat of DAIMONJI-Study
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 Ethical committee of Kyoto Medical Center
Address 1-1 Fukakusa-mukaihata-cho, Fushimi-ku
Tel 0756419161
Email narinari@kuhp.kyoto-u.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 大阪医科大学 (大阪府)
大阪赤十字病院(大阪府)
大阪府済生会野江病院 (大阪府)
大津市民病院(滋賀県)
大津赤十字病院(滋賀県)
関西電力病院(大阪府)
京都医療センター(京都府)
京都桂病院(京都府)
京都市立病院(京都府)
京都大学(京都府) 
倉敷中央病院(岡山県)
公立甲賀病院(滋賀県)
康生会武田病院(京都府)
神戸市立西神戸医療センター(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)
国立病院機構姫路医療センター(兵庫県)
滋賀県立成人病センター(滋賀県)
静岡市立静岡病院(静岡県)
社会保険小倉記念病院(福岡県)
JCHO大和郡山病院(奈良県)
島根県立中央病院(島根県)
私立岸和田市民病院(大阪府)
神鋼記念病院(兵庫県)
田附興風会北野病院(大阪府)
天理よろづ相談所病院(奈良県)
日本赤十字社和歌山医療センター(和歌山県)
兵庫医科大学(兵庫県)
兵庫県立尼崎医療センター(兵庫県)
福井赤十字病院(福井県)
三菱京都病院(京都府)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 22 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
2017 Year 10 Month 16 Day
Date of IRB
2015 Year 01 Month 18 Day
Anticipated trial start date
2017 Year 11 Month 02 Day
Last follow-up date
2020 Year 11 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2017 Year 10 Month 22 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033881

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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