UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031886 |
|---|---|
| Receipt number | R000036195 |
| Scientific Title | Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/03/26 18:46:04 |
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Basic information
Public title
Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Acronym
Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Scientific Title
Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early gastric cancer.
Scientific Title:Acronym
Safety and validity of robot-assisted laparoscopic gastrectomy using the da Vinci Xi operation system combined with ICG fluorescence navigation surgery for early 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 the safety and validity of robot (Da Vinci Xi) assisted gastrectomy for early gastric cancer with fluorescence navigation by gastric submucosal injection of ICG.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication rate of Grade 2 or higher according to Clavien-Dindo classification.
Key secondary outcomes
Completion rate of robot assisted gastrectomy, operation time, volume of blood loss, intraoperative complication rate of Grade 3 or higher according to CTCAE classification, Postoperative complication rate of Grade 3 or higher according to Clavien-Dindo classification, postoperative course evaluated by Inflammatory findings (WBC, CRP), body temperature, drain amylase value, number of days to post-operative flatus, postoperative hospital days), presence or absence of malignant tumor on dissected resected surface in pathological examination, number of excised lymph nodes.
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 | Maneuver |
Interventions/Control_1
Robot assisted gastrectomy using fluorescence navigation by gastric submucosal injection of ICG.
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)Patients diagnosed as clinical stage I and cT1 gastric cancer by preoperative examination.
(2)PS (ECOG) is 0 or 1.
(3)Body mass index (BMI) is less than 30.
(4)Patients without poorly controlled complications.
(5)No history of chemotherapy (including endocrine therapy) and/or radiotherapy for any carcinomas.
(6)It satisfies all the conditions below. (The latest examination value within 60 days before registration is used for all examination items.)
a)WBC >= 3,000 / mm 3
b)Plt >= 100,000 / mm 3
c)AST <= 100 IU / L, ALT <= 100 IU / L
d)T.Bil <= 2.0 g / dl
e)Serum creatinine <= 1.5 mg / dl
(7)The patient himself / herself signed the consent form approved by the ethics committee.
Key exclusion criteria
(1) Patients with active multiple primary cancers (simultaneous or metachronous with disease-free period within 5 years).
(2) Patients who have a history of frequent laparotomy and are expected to have severe intraperitoneal adhesions.
(3) Patients with a history of ICG hypersensitivity.
(4) Patients with severe complications (liver disease, renal disease, heart disease, blood disease, metabolic disease).
(5) Possible pregnancy or lactating female patients.
(6) Patients undergoing continuous systemic administration (ingestion or intravenous) of corticosteroids.
(7) Patients who are complicated of psychosis or psychiatric symptoms and judged to be difficult to participate in the exam.
(8) Patients judged inappropriate for participation in this study by the research director.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imamura |
Organization
Tokyo Meropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
imamurakazu@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Imamura |
Organization
Tokyo Meropolitan Tama Medical Center
Division name
Department of Surgery
Zip code
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo
TEL
042-323-5111
Homepage URL
imamurakazu@mac.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Tama Medical Center
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
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
東京都立多摩総合医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036195
