UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019366 |
|---|---|
| Receipt number | R000022393 |
| Scientific Title | Clinical evaluation of the safety of robotic gastrectomy using da Vinci surgical system (DVSS) for resectable gastric cancer |
| Date of disclosure of the study information | 2015/10/15 |
| Last modified on | 2019/10/22 02:51:54 |
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Basic information
Public title
Clinical evaluation of the safety of robotic gastrectomy using da Vinci surgical system (DVSS) for resectable gastric cancer
Acronym
Clinical evaluation of the safety of robotic gastrectomy for gastric cancer
Scientific Title
Clinical evaluation of the safety of robotic gastrectomy using da Vinci surgical system (DVSS) for resectable gastric cancer
Scientific Title:Acronym
Clinical evaluation of the safety of 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
To clarify safety of robotic gastrectomy using DVSS for gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The incidence of post-operative complications during one month after surgery.
Key secondary outcomes
Completion rate of robot assised surgery
The incidence of adverse event
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
Robotic 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologically diagnosed gastric adenocarcionoma
2) cStage I, II or III disease curably treated with total, proximal, or distal gastrectomy with lymph node dissection
3) Not indicated for endoscopic resection
4) Age over 18
5) Informed consent is obtained
Key exclusion criteria
1) Patients with psychiatric or mental disorders
2) Preoperative use of chemotherapy
3) Possibly pregnant, or breast feeding woman
4) Receiving steroids
5) Paticents with acute myocardial infaction in 6 months or with unstable ungina
6) Patients with pulmonary disease and require continuous oxygen therapy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
hiramatu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Hiramatsu |
Organization
Hamamatsu University School of Medicine
Division name
Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
TEL
053-435-2279
Homepage URL
hiramatu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, JAPAN
Tel
053-435-2680
rinri@hama-med.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
| 2015 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
24
Results
Robotic gastrectomy using DVSS was feasible.
Results date posted
| 2019 | Year | 10 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Distal gastrectomy were performed in 16 patients and total gastrectomy were performed in 8 cases.
Participant flow
From Oct 2015 to Nov 2017, 24 patients were enrolled for this study.
Adverse events
The incidence of post-operative complication greater than grade III was 0%. The overall incidence of adverse events was 20.8% (grade I; 16.7%, grade II; 4.1%).
Outcome measures
The incidence of post-operative complication greater than grade III was 0%. The overall incidence of adverse events was 20.8% (grade I; 16.7%, grade II; 4.1%). No patient required conversion to laparoscopic or open surgery; thus, the RG completion rate was 100%.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 01 | 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 | 10 | Month | 15 | Day |
Last modified on
| 2019 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022393
