UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of robot assisted gastric cancer surgery
Title of the study (Brief title)	A pilot study of robot assisted gastric cancer surgery
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of robot assisted laproscopic gastrectomy for gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Adverse event rate
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A group: We perform robot assisted radical resection for gastric cancer. We perform 5 years follow-up for the patients after the operation.
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	Case with gastric cancer for laparoscopic radical resection
Key exclusion criteria	The patients with pregnant possibilities. The patients with difficulty in decision making. The patients with contraindication of laparoscopic surgery. The patients with severe condition.
Target sample size	20

Research contact person
Name of lead principal investigator	Masaki Ohi
Organization	Mie University Hospital
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-231-5294
Email	mohi1012@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Shigeyuki Yoshiyama
Organization	Mie University Hospital
Division name	Department of Gastrointestinal and Pediatric Surgery
Address	2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL	059-231-5294
Homepage URL
Email	yoshiya@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	Mie University Hospital
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2017 Year 04 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 26 Day
Anticipated trial start date	2017 Year 04 Month 10 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	2017 Year 04 Month 04 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030823