UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017237 |
|---|---|
| Receipt number | R000019990 |
| Scientific Title | A prospective safety and feasibility study of robotic gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2016/02/19 17:17:53 |
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Basic information
Public title
A prospective safety and feasibility study of robotic gastrectomy for gastric cancer
Acronym
Robotic gastrectomy for gastric cancer
Scientific Title
A prospective safety and feasibility study of robotic gastrectomy for gastric cancer
Scientific Title:Acronym
Robotic gastrectomy for gastric cancer
Region
| Japan |
Condition
Condition
Gastric Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Morbidity
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Postoperative complications greater than Grade III according to Clavien-Dindo classification
Key secondary outcomes
Operation time
Blood loss
Number of dissected lymph nodes
Converion to laparotomy
Converion to laparoscopic surgery
Surgery-related Mortality
Short-term Mortality
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
Robotic gastrectomy
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
Histologically proven gastric adenocarcinoma
Diagnosed as cStageIA or cStageIB
Not applicable for endoscopic submucosal dissection
No invation to esophagus
Performance status of 0 or 1
No prior surgery in the upper abdomen
No prior chemotherapy or radiation therapy for cancers including gastric cancer
Informed consent obtained from the patient
Key exclusion criteria
Active mutiple primary cancers
Body Mass Index of over 30
With active infectious disease
Being pregnant or brestfeeding
With mental disorders
With myocardial infarction in 6 months or with unstable angina
With uncontrollable hypertension
With uncontrollable diabetes mellitus
With respiratory disorder requiring continuous oxgen therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2249
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2249
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya 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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | 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
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2016 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019990
