UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026860 |
|---|---|
| Receipt number | R000030823 |
| Scientific Title | A pilot study of robot assisted gastric cancer surgery |
| Date of disclosure of the study information | 2017/04/10 |
| Last modified on | 2017/04/04 21:31:06 |
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Basic information
Public title
A pilot study of robot assisted gastric cancer surgery
Acronym
A pilot study of robot assisted gastric cancer surgery
Scientific Title
A pilot study of robot assisted gastric cancer surgery
Scientific Title:Acronym
A pilot study of robot assisted gastric cancer surgery
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 of robot assisted laproscopic gastrectomy for gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse event rate
Key secondary outcomes
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
A group: We perform robot assisted radical resection for gastric cancer. We perform 5 years follow-up for the patients after the operation.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Case with gastric cancer for laparoscopic radical resection
Key exclusion criteria
The patients with pregnant possibilities.
The patients with difficulty in decision making.
The patients with contraindication of laparoscopic surgery.
The patients with severe condition.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Ohi |
Organization
Mie University Hospital
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5294
mohi1012@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeyuki Yoshiyama |
Organization
Mie University Hospital
Division name
Department of Gastrointestinal and Pediatric Surgery
Zip code
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-231-5294
Homepage URL
yoshiya@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
Funding Source
Organization
Mie University Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 04 | Month | 10 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 10 | 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
| 2017 | Year | 04 | Month | 04 | Day |
Last modified on
| 2017 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030823
