UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study of early enteral feeding utilizing arginine after total gastrectomy and pancreaticoduodenectomy
Title of the study (Brief title)	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	Yasuko Okamoto
Organization	Hamamatsu Medical Center
Division name	Clinical Nutritional Management
Address	Hamamatsu city nakaku tmitukacho 328
TEL	0534537111
Email	yasuko.ok@hmedc.or.jp

Public contact
Name of contact person	Yasuko Okamoto
Organization	Hamamatsu Medical Center
Division name	Clinical Nutritional Management
Address	Hamamatsu city nakaku tmitukacho 328
TEL	0534537111
Homepage URL
Email	j08nuua38c@hi3.enjoy.ne.jp

Sponsor
Institute	Hamamatsu Medical Center
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 01 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003387