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

Email



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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name