UMIN-CTR Clinical Trial

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	Preinitiation
Date of protocol fixation	2020 Year 07 Month 09 Day
Date of IRB
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	2020 Year 10 Month 26 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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