UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation of nutritional recovery after open and laparoscopic gastrectomies for early gastric cancer
Title of the study (Brief title)	CCOG1204
Region	Japan

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

Objectives
Narrative objectives1	We will evaluate that the nutritional recovery after laparoscopic gastrectomies for gastric cancer patients who are diagnosed to be Stage 1A/1B is superior to after open gastrectomies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Variation of the total amount of muscles 6 months after open and laparoscopic gastrectomy
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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. Gastric cancer patients who are diagnosed to be Stage 1A/1B according to the Japanease classification for gastric cancer 2. Patients who are going to undergo distal gastrectomy
Key exclusion criteria	1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Body mass index more than 30 3) Uncontrollable hypertension or uncontrollable diabetes mellitus 4) Continuous systemic steroid therapy 5) Otherwise considered inadequate for inclusion in this trial by the physician
Target sample size	165

Research contact person
Name of lead principal investigator	Yasuhiro Kodera
Organization	Nagoya University, Graduate School of Medicine
Division name	Gastroenterorogical Surgery
Address	65 Tsurumai-cho Showa-ku Nagoya city
TEL	052-744-2253
Email	ykodera@med.nagoya-u.ac.jp

Public contact
Name of contact person	Hidenobu Matsushita
Organization	Tosei General Hospital
Division name	Surgery
Address	160 Nishioiwake-cho Seto city
TEL	0561-82-5101
Homepage URL
Email	hidenobu@med.nagoya-u.ac.jp

Sponsor
Institute	Chubu Clinical Oncology Group
Institute
Department

Funding Source
Organization	Chubu Clinical Oncology Group
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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 09 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 30 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Key inclusion criteria: 1. Gastric cancer patients who are diagnosed to be Stage 1A/1B according to the Japanease classification for gastric cancer 2. Patients who are going to undergo distal gastrectomy Key exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ 2) Body mass index more than 30 3) Uncontrollable hypertension or uncontrollable diabetes mellitus 4) Continuous systemic steroid therapy 5) Otherwise considered inadequate for inclusion in this trial by the physician

Management information
Registered date	2014 Year 09 Month 17 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017664