UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028807
Receipt number R000032966
Scientific Title Prospective study of Robot assisted laparoscopic surgery for gastric cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2020/03/11 18:32:30

* 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

Prospective study of Robot assisted laparoscopic surgery for gastric cancer

Acronym

Prospective study of Robot assisted laparoscopic surgery for gastric cancer

Scientific Title

Prospective study of Robot assisted laparoscopic surgery for gastric cancer

Scientific Title:Acronym

Prospective study of Robot assisted laparoscopic surgery for gastric cancer

Region

Japan


Condition

Condition

gastric cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We reveal a safety and efficacy of robot assisted laparoscopic surgery for gastric cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

mortality and morbidity of the operation

Key secondary outcomes

operation time, bleeding, post operative course


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

da Vinci surgrical system

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. gastric cancer (Stage I,II)
2. no major complication

Key exclusion criteria

1.double cancer patient
2. history of laparotomy
3. major complication( liver, kidney, heart)

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tetsu Fukunaga

Organization

Juntendo University school of medicine

Division name

Department of Gastroenterology and Minimally Invasive Surgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

t2fukunaga@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuji Ishibashi

Organization

Juntendo University school of medicine

Division name

Department of Gastroenterology and Minimally Invasive Surgery

Zip code


Address

Hongo 2-1-1, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

yj-ishibashi@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University school of medicine

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

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 09 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

Terminated

Date of protocol fixation

2017 Year 07 Month 28 Day

Date of IRB

2017 Year 07 Month 25 Day

Anticipated trial start date

2017 Year 09 Month 01 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry

2027 Year 03 Month 31 Day

Date trial data considered complete

2027 Year 03 Month 31 Day

Date analysis concluded

2027 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 08 Month 24 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name