UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019366
Receipt No. 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 (Ver. 6)

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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
Email 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
Email hiramatu@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022393