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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010011
Receipt No. R000011726
Scientific Title Study of feasibility and safety in Robot-assisted proximal gastrectomy with esophago-gastrostomy using da Vinci S Surgical System for gastric cancer.
Date of disclosure of the study information 2013/02/12
Last modified on 2013/02/11

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Basic information
Public title Study of feasibility and safety in Robot-assisted proximal gastrectomy with esophago-gastrostomy using da Vinci S Surgical System for gastric cancer.
Acronym Study of feasibility and safety in Robot-assisted proximal gastrectomy.
Scientific Title Study of feasibility and safety in Robot-assisted proximal gastrectomy with esophago-gastrostomy using da Vinci S Surgical System for gastric cancer.
Scientific Title:Acronym Study of feasibility and safety in Robot-assisted proximal 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 feasibility and safety of robot-assisted proximalgastrectomy with esophago-gastrostomy 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 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University
Division name Okayama University Hospital, Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Nishizaki
Organization Okayama University
Division name Okayama University Hospital, Department of Gastroenterological Surgery
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL 086-235-7257
Homepage URL
Email

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2013 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2013 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 02 Month 11 Day
Last modified on
2013 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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