UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of the safety and the usefulness of robot assisted distal gastrectomy with D2 lymphadenectomy for gastric cancer
Title of the study (Brief title)	Clinical evaluation of the safety of RADG with D2
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 and the usefulness of robot assisted distal gastrectomy with D2
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The incidence of post-operative complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess)
Key secondary outcomes	Completion rate of robot assised surgery The incidence of adverse event

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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	Robot assisted surgery
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1)Over 20 years of age 2)Survival 12 months or more expected 3)Distal gastrectomy 4)Performance Status PS0-1 5)Provision of written informed consent
Key exclusion criteria	1)Severer adhision in abdominal cavity 2)Possibly pregnant or breast feeding woman 3)In case of malignant cells or intraperitoneal seeding are observed 4)Other, if the principal investigator has been deemed inappropriate
Target sample size	10

Research contact person
Name of lead principal investigator	Satoshi Hirano
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery II
Address	W7, N7, Kita-ku, Sapporo, Hokkaido Japan
TEL	011-706-7714
Email	satto@med.hokudai.ac.jp

Public contact
Name of contact person	Yuma Ebihara
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterological Surgery II
Address	W7, N7, Kita-ku, Sapporo, Hokkaido Japan
TEL	011-706-7714
Homepage URL
Email	yuma-ebi@wc4.so-net.ne.jp

Sponsor
Institute	Hokkaido University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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	北海道大学医学部付属病院（北海道）

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 10 Day
Anticipated trial start date	2014 Year 01 Month 06 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	2014 Year 01 Month 06 Day
Last modified on	2016 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014903