UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of feasibility and safety in Robot-assisted laparoscopic gastrectomy using da Vinci S Surgical System for gastric cancer.
Title of the study (Brief title)	feasibility and safety in Robot-assisted gastrectomy for gastric cancer.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the feasibility and safety of robot-assisted laparoscopic gastrectomy using da Vinci S Surgical system.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	frequency of adverse events
Key secondary outcomes	the accomplishment rate

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 Maneuver
Interventions/Control_1	The use of da Vinci S surgical System in laparoscopic gastrectomy for gastric cancer
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Histologically proven gastric adenocarcinoma. 2) cStage IA(T1N0) . 3) No history of upper abdominal surgery and no history of intestinal resection. 4) Sufficient organ functions. 5) Written informed consent.
Key exclusion criteria	(1)Active synchronous cancers. (2)Women during pregnancy or breast-feeding. (3)Severe mental disease. (4)Cases which is unsuitable for laparoscopic surgery. (5)Cases which the investigators think inadequate to this study.
Target sample size	10

Research contact person
Name of lead principal investigator	Toshiyoshi Fujiwara
Organization	Okayama University
Division name	Okayama University Hospital, Department of Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	+81-86-235-7257
Email	skagawa@md.okayama-u.ac.jp

Public contact
Name of contact person	Shunsuke Kagawa
Organization	Okayama University
Division name	Okayama University Hospital, Department of Gastroenterological Surgery
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL	+81-86-235-7257
Homepage URL
Email	skagawa@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

Funding Source
Organization	None
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	岡山大学病院

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 02 Month 01 Day
Anticipated trial start date	2011 Year 02 Month 02 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 02 Month 02 Day
Last modified on	2018 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005944