UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026770 |
|---|---|
| Receipt number | R000003387 |
| Scientific Title | Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2017/03/29 21:15:27 |
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Basic information
Public title
Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy
Acronym
Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy
Scientific Title
Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy
Scientific Title:Acronym
Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy
Region
| Japan |
Condition
Condition
after total gastrectomy and pancreaticoduodenectomy
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the clinical and economic usufulness of the early tube enteral nutrition after total gastrectomy and pancreaticoduodenectomy comparing the classical total parenteral nutrition, especially paying attention to a special amino acid, arginine.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
evaluate the clinical and economic usufulness of the early tube enteral nutrition after total gastrectomy and pancreaticoduodenectomy comparing the classical total parenteral nutrition, especially paying attention to a special amino acid, arginine.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Food | Maneuver |
Interventions/Control_1
parenteral nutrition (PN) alone (PN group)
Interventions/Control_2
early enteral arginine-rich nutrition (EAN) supplemented with parenteral nutrition (EAN group)
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
| 56 | years-old | <= |
Age-upper limit
| 82 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
gastrectomy for curative intent PANCREATICODUODENECY
Key exclusion criteria
no operation
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuko Okamoto |
Organization
Hamamatsu Medical Center
Division name
Clinical Nutritional Management
Zip code
Address
Hamamatsu city nakaku tmitukacho 328
TEL
0534537111
yasuko.ok@hmedc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuko Okamoto |
Organization
Hamamatsu Medical Center
Division name
Clinical Nutritional Management
Zip code
Address
Hamamatsu city nakaku tmitukacho 328
TEL
0534537111
Homepage URL
j08nuua38c@hi3.enjoy.ne.jp
Sponsor or person
Institute
Hamamatsu Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nestle Nutrition Company, Tokyo, Japan)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hamamatsu University School of Medicine,
Name of secondary funder(s)
no
IRB Contact (For public release)
Organization
Address
Tel
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
浜松医療センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | 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
No differences were observed between two groups with regard to postoperative complication, length of hospital stay, oral intake amount, and nutritional status. The serum arginine profile was similar between two groups: it decreased significantly on 1 POD, and gradually returned to the preoperative level by 7 POD. Importantly, the nitrogen balance decreased over time until 7 POD in the TPN group, while it turned to positive by 7 POD in the EAN group. Furthermore, muscle atrophy accessed by lean body mass decrease was smaller in the EAN group.
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
| 2010 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 01 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2017 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003387
