UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018168 |
|---|---|
| Receipt number | R000021034 |
| Scientific Title | Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2024/01/10 14:21:34 |
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Basic information
Public title
Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer
Acronym
RDG for stage1 GC
Scientific Title
Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer
Scientific Title:Acronym
RDG for stage1 GC
Region
| Japan |
Condition
Condition
cStage1 gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of robot-assisted laparoscopic gastrectomy for patients with cStage1 gastric cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of grade 3 or more adverse event according to the Clavien-Dindo classification
Key secondary outcomes
Incidence of grade 2 or more adverse event according to the Clavien-Dindo classification, Completion rate of robot assisted laparoscopic surgery, Relapse-free survival
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
Robot assisted laparoscopic 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
1)Histologically proven gastric adenocarcinoma and diagnosed as cStage1
2)Excluded from the indication of ESD
3)Body mass index of less than 30
4)Performance status of 0 or 1
5)Informed consent obtained from the patient
Key exclusion criteria
1)Previous laparotomy(excluding appendectomy and laparoscopic surgery)
2)Indication for emergency surgery
3)With active intestinal bleeding
4)With bowel obstruction
5)With Heart disease associated with symptoms(including unstable ungina or acute myocardial infarction or heart failure)
6)With pulmonary disease requiring continuous oxygen therapy
7)With uncontrolled diabetes mellitus
8)With uncontrolled hypertension
9)With Acute myocardial infarction in 6 months
10)With a history of previous deep thrombophlebitis or pulmonary embolism
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Eigo |
| Middle name | None |
| Last name | Otsuji |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5527
otsuji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Kazuma |
| Middle name | None |
| Last name | Okamoto |
Organization
Kyoto Prefectural University of Medicine
Division name
Division of Digestive Surgery
Zip code
602-8566
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5527
Homepage URL
kazuma@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine
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
Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
Tel
075-251-5337
rinri@koto.kpu-m.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
京都府立医科大学附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
Completed
Date of protocol fixation
| 2015 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021034
