UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008628 |
|---|---|
| Receipt number | R000010137 |
| Scientific Title | Efficacy of early administration of enteral nutrition after liver resection |
| Date of disclosure of the study information | 2012/08/06 |
| Last modified on | 2015/03/13 09:44:59 |
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Basic information
Public title
Efficacy of early administration of enteral nutrition after liver resection
Acronym
Efficacy of early administration of enteral nutrition after liver resection
Scientific Title
Efficacy of early administration of enteral nutrition after liver resection
Scientific Title:Acronym
Efficacy of early administration of enteral nutrition after liver resection
Region
| Japan |
Condition
Condition
Liver disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the benefit of early administration of enteral nutrition after liver resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of postoperative infectious complication
Key secondary outcomes
The frequency of postoperative complication, liver failure, surgical site infection and postoperative hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Early administration of enteral nutrition group. The patients of this group will receive enteral nutrition through jejunostomy tube.
Interventions/Control_2
Control group. The patients of this group will not receive enteral nutrition through jejunostomy tube.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients who will undergo hepatectomy for liver disease.
Key exclusion criteria
The patients who cannot underwent jejunostomy.
The patients who will not undergo 2 segments or more liver resection.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuniya Tanaka |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2650
U17-92TS@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kuniya Tanaka |
Organization
Yokohama city university graduate school of medicine
Division name
Department of gastroenterological surgery
Zip code
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
045-787-2650
Homepage URL
U17-92TS@med.teikyo-u.ac.jp
Sponsor or person
Institute
Yokohama city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 06 | Day |
Last modified on
| 2015 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010137
