UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045862 |
|---|---|
| Receipt number | R000051284 |
| Scientific Title | Safety of the robot-assisted laparoscopic gastrectomy |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2021/10/25 22:30:22 |
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Basic information
Public title
Safety of the robot-assisted laparoscopic gastrectomy
Acronym
Da Vinci-gastrectomy
Scientific Title
Safety of the robot-assisted laparoscopic gastrectomy
Scientific Title:Acronym
Da Vinci-gastrectomy
Region
| Japan |
Condition
Condition
Stage I-II gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety of robot-assisted gastrectomy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall adverse event occurrence 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 | Maneuver |
Interventions/Control_1
Robot-assisted gastrectomy (distal or total gastrectomy) will be performed on cStage I-II gastric cancer patients.
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
(1) Gastric cancer patients
(2) cStage I-II
(3) ECOG Performance Status Scale: 0-1
(4) Patient age of 20 year-old or over
(5) Both male and female
(6) Written informed consent is obtained
Key exclusion criteria
(1) With multiple primary cancer
(2) Uncontrollable mental disorder
(3) Long-term steroid therapy
(4) Severe renal disfunction
(5) Uncontrollable hypertension or diabetes
(6) Pregnant case
(7) Other conditions judged ineligible by physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Imoto |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
hirofumi-i@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Imoto |
Organization
Tohoku University Hospital
Division name
Department of Surgery
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7205
Homepage URL
hirofumi-i@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital
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
Tohoku University Hospital
Address
1-1, Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel
022-717-7205
hospital-koe@grp.tohoku.ac.jp
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
| 2021 | Year | 10 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051284
