UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010011 |
|---|---|
| Receipt number | 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 23:06:24 |
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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
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
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011726
