UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The usefulness and safety study of robot assisted laparoscopic gastrectomy
Title of the study (Brief title)	The usefulness and safety study of robot assisted laparoscopic gastrectomy
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the usefulness and safety of robot assisted laparoscopic gastrectomy for gastric cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The incidence of postoperative complication during 30 days after surgery.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Robot assisted laparoscopic gastrectomy
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Histologically confirmed gastric cancer 2. Clinically diagnosed T1 or T2N0 3. Enough main organ functions to perform operation 4. To perform conventional laparoscopic gastrectomy safely 5. Patients aged 20 years and more 6. informed consent obtained from the patient
Key exclusion criteria	1. Remnant gastric cancer 2. Active multiple primary cancer 3. Patients with T3 and more. Patients with bulky lymph node metastasis. 4. Patients with severe intra-abdominal adhesion 5. Severe comobidities(ex: severe heart disease, plumonary disease, uncontrolable hypertension or diabetes) 6. Being pregnant 7. Severe psychiatric disease 8. Patients whom doctors consider unsuitable
Target sample size	120

Research contact person
Name of lead principal investigator	Yasushi Rino
Organization	Yokohama city university
Division name	Department of Surgery
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL	+81-45-787-2800
Email	rino@yokohama-cu.ac.jp

Public contact
Name of contact person	Tsutomu Sato
Organization	Yokohama city university
Division name	Department of Surgery
Address	3-9 Fukuura, Kanazawa, Yokohama, Kanagawa, Japan
TEL	+81-45-787-2800
Homepage URL
Email	t_sato@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city university
Institute
Department

Funding Source
Organization	Yokohama city university
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	2015 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 03 Month 06 Day
Anticipated trial start date	2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 02 Day
Last modified on	2017 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019689