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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040383
Receipt No. R000046084
Scientific Title A meta-analysis of the effect of immunonutrition on postoperative outcomes in pancreaticoduodenectomy
Date of disclosure of the study information 2020/05/12
Last modified on 2020/05/13

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Basic information
Public title A meta-analysis of the effect of immunonutrition on postoperative outcomes in pancreaticoduodenectomy
Acronym A meta-analysis of the effect of immunonutrition on postoperative outcomes in pancreaticoduodenectomy
Scientific Title A meta-analysis of the effect of immunonutrition on postoperative outcomes in pancreaticoduodenectomy
Scientific Title:Acronym A meta-analysis of the effect of immunonutrition on postoperative outcomes in pancreaticoduodenectomy
Region
Japan

Condition
Condition Patients who underwent pancreaticoduodenectomy
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this meta-analysis was to clarify the significance of immunonutrition(IM) on short-term outcomes including pancreaticoduodenectomy(PD)-related complications in patients undergoing PD. Moreover, we explored further analysis to identify the association between IM and the incidence of each infectious complication after PD.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The aim of this meta-analysis was to clarify the significance of immunonutrition(IM) on short-term outcomes including pancreaticoduodenectomy(PD)-related complications in patients undergoing PD.
Key secondary outcomes Moreover, we explored further analysis to identify the association between IM and the incidence of each infectious complication after PD.
Subgroup analysis including sensitivity analysis and source of funding (industry vs non-industry).

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The present study included RCT and retrospective studies in English, which compared outcomes between patients who received IM (IM group) or standard treatment (control group).
Key exclusion criteria Records without abstracts, conference abstracts, case reports, and reviews were excluded.
Target sample size 670

Research contact person
Name of lead principal investigator
1st name Kosei
Middle name
Last name Takagi
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho
TEL +81-86-223-7151
Email kotakagi15@gmail.com

Public contact
Name of contact person
1st name Kosei
Middle name
Last name Takagi
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code 700-8558
Address 2-5-1 Shikata-cho
TEL +81-86-223-7151
Homepage URL
Email kotakagi15@gmail.com

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization NA
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 NA
Address NA
Tel +81-86-223-7151
Email kotakagi15@gmail.com

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

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 12 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 670
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 No longer recruiting
Date of protocol fixation
2020 Year 05 Month 12 Day
Date of IRB
2020 Year 03 Month 01 Day
Anticipated trial start date
2020 Year 05 Month 12 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ethical approval: No ethical approval or informed consent statement was required for this review article.

Management information
Registered date
2020 Year 05 Month 12 Day
Last modified on
2020 Year 05 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046084

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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