UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042245 |
|---|---|
| Receipt number | R000046863 |
| Scientific Title | Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7. |
| Date of disclosure of the study information | 2020/11/30 |
| Last modified on | 2021/04/27 18:15:08 |
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Basic information
Public title
Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7.
Acronym
Can we prevent pancreatic fistula after DP by delaying the initiation of food intake? A randomized controlled trial day4 vs day7.
Scientific Title
Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7.
Scientific Title:Acronym
Can we prevent pancreatic fistula after distal pancreatectomy by delaying the initiation of food intake? A randomized controlled trial day4 vs day7.
Region
| Japan |
Condition
Condition
Patients scheduled to undergo distal pancreatectomy regardless of primary disease, whether open or laparoscopic
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the impact of the timing of meal initiation after distal pancreatectomy on the incidence of pancreatic fistula incidence using a randomized controlled trial and to establish an appropriate postoperative management plan in our hospital.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of post-operative pancreatic fistula
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The timing of the initiation of food intake after distal pancreatectomy POD4
Interventions/Control_2
The timing of the initiation of food intake after distal pancreatectomy POD7
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo distal pancreatectomy regardless of primary disease, whether open or laparoscopic
Key exclusion criteria
Patients for whom it is deemed necessary to perform a gastrointestinal resection or gastrointestinal anastomosis due to medical reasons
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | koji |
| Middle name | |
| Last name | imai |
Organization
Asahikawa Medical University
Division name
Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code
0788510
Address
2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166682503
kimai@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | koji |
| Middle name | |
| Last name | imai |
Organization
Asahikawa Medical University Hospital
Division name
Hepato-Biliary-Pancreatic and Transplant Surgery
Zip code
0788510
Address
2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
TEL
0166682503
Homepage URL
kimai@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
2-1, Midorigaoka-Higashi, Asahikawa, Hokkaido
Tel
0166682503
kimai@asahikawa-med.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
旭川医科大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 30 | 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
| 2020 | Year | 07 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 26 | Day |
Last modified on
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046863
| 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 |
