UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020886 |
|---|---|
| Receipt number | R000024081 |
| Scientific Title | Clinical study of robotic gastrectomy for gastric cancer |
| Date of disclosure of the study information | 2016/02/04 |
| Last modified on | 2019/04/20 22:01:35 |
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Basic information
Public title
Clinical study of robotic gastrectomy for gastric cancer
Acronym
Clinical study of robotic gastrectomy for gastric cancer
Scientific Title
Clinical study of robotic gastrectomy for gastric cancer
Scientific Title:Acronym
Clinical study 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 evaluate the safety and feasility of robotic gastrectomy for gastric cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative complication
Postoperative complication (within 30 days)
Operative mortality
Key secondary outcomes
Overall survival, Disease free survival
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
| Maneuver |
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Pathologically confirmed gastric cancer
2)Amenable to curative resection
3)ECOG Performance Status 0 or 1
4) Written informed consent
Key exclusion criteria
1) Patient with severe phyciatric disease
2) Patient who is judged to be inappropriate as subject to this study by the principa investigator
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okabe |
Organization
Otsu City Hospital
Division name
Department of Surgery
Zip code
420
Address
Motomiya 2-9-9, Otsu City
TEL
81-77-522-4607
hokabe@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Okabe |
Organization
Otsu City Hospital
Division name
Department of Surgery
Zip code
5200804
Address
Motomiya 2-9-9, Otsu City
TEL
81-77-522-4607
Homepage URL
hokabe@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Otsu City Hospital
Institute
Department
Personal name
Funding Source
Organization
Otsu City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics comittiee, Otsu City Hospital
Address
2-9-9 motomiya, Otsu
Tel
077-522-4607
och1020@och.or.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
| 2016 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007%2Fs00595-019-01802-z
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007%2Fs00595-019-01802-z
Number of participants that the trial has enrolled
115
Results
A total of 115 patients were enrolled.Two patients developed intraoperative complications (1.7%), but no cases required conversion to open surgery. Postoperative complications of Clavien Dindo grade II or higher occurred in 11 patients (9.6%). There was
no mortality. A multivariate analysis indicated that a high body mass index and pancreatic compression by an assistant for
longer than 20 min were independent risk factors for postoperative complications (P = 0.029 and P = 0.010).
Results date posted
| 2019 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 03 | Month | 30 | Day |
Baseline Characteristics
Age, median (range) 68 (34to86)
Body mass index, median (range) 22.4 (15.7 to 30.1)
Sex, n (%)
Male 75 (65%)
Female 40 (35%)
ECOGPS, n (%)
0 108 (94%)
1 7 (6%)
ASAPS, n (%)
1 26 (23%)
2 84 (73%)
3 5 (4%)
Preoperative chemotherapy, n (%)
No 102 (89%)
Yes 13 (11%)
Clinical T classification, n (%)
cT1a/b 10/58 (59%)
cT2 14 (12%)
cT3 19 (17%)
cT4a/b 13/1 (12%)
Clinical stage, n (%)
IA/IB 59/20 (69%)
IIA/IIB 8/13 (18%)
IIIA/IIIB/IIIC 7/6/2 (12%)
Participant flow
A total of 115 patients were enrolled.
Adverse events
Postoperative complications of Clavien Dindo grade II or above occurred in 11 patients (9.6%).
Outcome measures
Postoperative complications of Clavien Dindo grade II or higher occurred in 11 patients (9.6%). There was
no mortality.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2017 | Year | 12 | 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
| 2016 | Year | 02 | Month | 04 | Day |
Last modified on
| 2019 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024081
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