UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040383 |
|---|---|
| Receipt number | 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 | 2020/07/19 23:11:12 |
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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
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
kotakagi15@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
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
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
Completed
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 | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046084
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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