UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029662 |
|---|---|
| Receipt number | 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 | 2023/11/10 11:37:35 |
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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
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
narinari@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Medical Center
Secretariat of DAIMONJI-Study
Institute
Department
Personal name
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
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
https://drive.google.com/file/d/1Pq05AIeYm9tmUOfMZUz5-4Q_Ldgb3Bvq/view?usp=sharing
Publication of results
Published
Result
URL related to results and publications
https://drive.google.com/file/d/1DbDdExSTSpANwARDe8kqws4dP5ee2hE3/view?usp=sharing
Number of participants that the trial has enrolled
200
Results
Refer to URL related to results and publications
Results date posted
| 2023 | Year | 11 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to URL related to results and publications
Participant flow
Refer to URL related to results and publications
Adverse events
Refer to URL related to results and publications
Outcome measures
Refer to URL related to results and publications
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
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
| 2021 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 30 | Day |
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
| 2023 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033881
