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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name