UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028807 |
|---|---|
| Receipt number | R000032966 |
| Scientific Title | Prospective study of Robot assisted laparoscopic surgery for gastric cancer |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/03/11 18:32:30 |
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Basic information
Public title
Prospective study of Robot assisted laparoscopic surgery for gastric cancer
Acronym
Prospective study of Robot assisted laparoscopic surgery for gastric cancer
Scientific Title
Prospective study of Robot assisted laparoscopic surgery for gastric cancer
Scientific Title:Acronym
Prospective study of Robot assisted laparoscopic surgery for gastric cancer
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We reveal a safety and efficacy of robot assisted laparoscopic surgery for gastric cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality and morbidity of the operation
Key secondary outcomes
operation time, bleeding, post operative course
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
da Vinci surgrical system
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. gastric cancer (Stage I,II)
2. no major complication
Key exclusion criteria
1.double cancer patient
2. history of laparotomy
3. major complication( liver, kidney, heart)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsu Fukunaga |
Organization
Juntendo University school of medicine
Division name
Department of Gastroenterology and Minimally Invasive Surgery
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
t2fukunaga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ishibashi |
Organization
Juntendo University school of medicine
Division name
Department of Gastroenterology and Minimally Invasive Surgery
Zip code
Address
Hongo 2-1-1, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
yj-ishibashi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University school of medicine
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 24 | Day |
Last modified on
| 2020 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032966
