UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016349 |
|---|---|
| Receipt number | R000018979 |
| Scientific Title | A pilot study of robot assisted gastrectomy with nodal dissection for clinical stage I gastric cancer using the da Vinci Si surgical system |
| Date of disclosure of the study information | 2015/01/27 |
| Last modified on | 2018/07/31 09:13:39 |
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Basic information
Public title
A pilot study of robot assisted gastrectomy with nodal dissection for clinical stage I gastric cancer using the da Vinci Si surgical system
Acronym
Lap-G da Vinci
Scientific Title
A pilot study of robot assisted gastrectomy with nodal dissection for clinical stage I gastric cancer using the da Vinci Si surgical system
Scientific Title:Acronym
Lap-G da Vinci
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety of robot-assisted laparoscopic gastrectomy with lymph node dissection applied to gastric cancer of cStageIA/IB excluded from the indication of ESD.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of intraperitoneal inflectional complication (anastomotic leakage, pancreatic fistula and intraperitoneal abscess)
Key secondary outcomes
Incidence of accomplishment of robotic surgery, incidence of adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Robot-assisted surgery
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.Histolically proved as gastric carcinoma by biopsy
2.cStageIA(T1N0) or cStageIB(T1N1, T2N0) diagnosed by imaging examinations
3.Excluded from the indication of ESD using gastroendoscopy
4.No invasion to the esophagus or duodenum. Radical resection is expected by distal gastrectomy or spleen-preserving total gastrectomy. Regardless of number of lesions.
5.PS(ECOG) 0 or 1
6.Full informed consent with candidates by the document
Key exclusion criteria
1.BMI exceeding 30
2.History of surgery in the upper abdomen, or surgery with intestinal resection
3. History of chemotherapy (including hormonal therarpy) or radiation also for other neoplasm lesions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Kinoshita |
Organization
National Cancer Center Hospital East
Division name
Gastric Surgery Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, 277-8577 Chiba
TEL
04-7133-1111
takkinos@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Kinoshita |
Organization
National Cancer Center Hospital East
Division name
Gastric Surgery Division
Zip code
Address
6-5-1 Kashiwanoha, Kashiwa, 277-8577 Chiba
TEL
04-7133-1111
Homepage URL
takkinos@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
No
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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 11 | Month | 13 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018979
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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