UMIN-CTR Clinical Trial

Basic information
Public title	Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Acronym	Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Scientific Title	Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Scientific Title:Acronym	Effect of early oral intake after gastric resection at multicenter randomized controlled trials.
Region	Japan

Condition
Condition	Gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examine the influence of early oral intake after gastric resection on safety, Hospital stay, QOL, medical economy and brain-gut interaction.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II,III

Assessment
Primary outcomes	Postoperative hospital stay
Key secondary outcomes	Arrows day of discharge

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Oral intake of special diet i-Eat from noon of POD1 to POD 3.
Interventions/Control_2	Control group take normal nutritional care.
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	1) planned surgical procedure total or distal gastrectomy. 2) cStage:IA-IIIB 3) performance status:0-1 4) age:20-80 years 5) diagnosed as oral intake is possible within 1 post operative day. 6) written informed consent must be obtained from patients.
Key exclusion criteria	1) considered to be on a ventilator after surgery. 2) plan to chemotherapy or chemo-radiotherapy during hospitalization. 3) receiving neoadjuvant chemotherapy.. 4) patient who have another active malignancy. 5) receiving combined resection (gall bladder is excepted). 6) past history of intestinal resection (resection of colon polyp and appendicitis are excepted). 7) severe complication such as heart disease ,respiratory disease, hepatic disorder, renal disorder. 8) drug administration influence of intestinal hormone such as KAMPO. 9) patients who plan to blood infusion during perioperative period. 10) past history of food allergy. 11) patients considered inappropriate by the study investigator.
Target sample size	400

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Seto
Organization	The University of Tokyo
Division name	Department of Gastrointestinal Sugery
Zip code	1138655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3815-5411
Email	seto-tky@umin.ac.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Shimizu
Organization	SANNO HOSPITAL
Division name	Department of surgery
Zip code	1070052
Address	8-10-16, Akasaka, Minato-ku, Tokyo
TEL	03-3402-3151
Homepage URL
Email	nshimizu@iuhw.ac.jp

Sponsor
Institute	The University of Tokyo
Institute
Department

Funding Source
Organization	EN Otsuka Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
Tel	03-5841-0818
Email	ethics@m.u-tokyo.ac.jp

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	2014 Year 05 Month 22 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	2013 Year 09 Month 26 Day
Date of IRB	2013 Year 09 Month 26 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2016 Year 07 Month 20 Day
Date trial data considered complete	2016 Year 08 Month 29 Day
Date analysis concluded	2017 Year 02 Month 09 Day

Other
Other related information

Management information
Registered date	2014 Year 05 Month 22 Day
Last modified on	2022 Year 05 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016350