UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007534 |
|---|---|
| Receipt number | R000008896 |
| Scientific Title | Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy. |
| Date of disclosure of the study information | 2012/03/20 |
| Last modified on | 2016/03/19 21:30:53 |
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Basic information
Public title
Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy.
Acronym
Effects of perioperative administration of carbohydrate and amino acids
Scientific Title
Effects of perioperative administration of carbohydrate and amino acids on Intraoperative vital signs and postoperative recovery after hepatectomy.
Scientific Title:Acronym
Effects of perioperative administration of carbohydrate and amino acids
Region
| Japan |
Condition
Condition
Patients who are scheduled to undergo hepatectomy.
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of perioperative administration of carbohydrate and amino acids on intraoperative vital signs and postoperative recovery in patients who are going to undergo hepatectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative vital signs (body temperature, blood pressure, etc.)
Postoperative complications including hepatic failure, bile leakage, and hemorrhage.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Preoperative intake of hepan (carbohydrate and amino acids rich enteral nutrition)+Intraoperative amino acid infusion
Interventions/Control_2
Prohibit preoperative oral intake within 24 hours. Intraoperative lactoringer infusion
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are going to undergo hepatectomy.
Key exclusion criteria
1. Patients who did not agree with the participation.
2. Patients with a history of chmo- and/or radio-therapy.
3. Patients with a history of hepatectomy.
4. Patients with severe complications.
5. Patients with severe diabetes.
6. Patients who need continuous administration of steroid.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nagino Masato |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yokoyama Yukihiro |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgery, Division of Surgical Oncology
Zip code
Address
TEL
Homepage URL
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
N.A.
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 | 03 | Month | 20 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 19 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 19 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 19 | Day |
Last modified on
| 2016 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008896
