UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024297
Receipt number R000027982
Scientific Title Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system
Date of disclosure of the study information 2017/01/01
Last modified on 2018/06/20 00:04:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system

Acronym

Feasibility and safety of robot-assisted gastrectomy

Scientific Title

Clinical study for feasibility and safety of robot-assisted gastrectomy using da Vinci surgical system

Scientific Title:Acronym

Feasibility and safety of robot-assisted gastrectomy

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To meet the criteria for participating in multicenter clinical trial of robot-assisted gastrectomy

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intraoperative and postoperative morbidity

Key secondary outcomes



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

Maneuver

Interventions/Control_1

Robot-assisted 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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Pathologically diagnosed with primary gastric cancer
2) Clinically diagnosed with stage I or II
3) Not indicated for EMR or ESD
4) 40 years old or more
5) Written informed concent

Key exclusion criteria

1) Preoperative therapy such as neoadjuvant chemotherapy
2) Patients with some difficulty in participating in the study such as mental disorder

Target sample size

7


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyoshi Fujiwara

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-7257

Email

toshi_f@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyoshi Fujiwara

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Gastroenterological Surgery

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama, Japan

TEL

086-235-7257

Homepage URL


Email

toshi_f@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

N/A

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


Address


Tel


Email



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

2017 Year 01 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

2016 Year 09 Month 27 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 10 Month 04 Day

Last modified on

2018 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027982


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name