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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042245
Receipt No. 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

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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
Email 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
Email kimai@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046863

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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