UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018168
Receipt number R000021034
Scientific Title Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer
Date of disclosure of the study information 2015/10/01
Last modified on 2024/01/10 14:21:34

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Basic information

Public title

Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer

Acronym

RDG for stage1 GC

Scientific Title

Clinical study on safety of robot assisted gastrectomy with nodal dissection for clinical stage1 gastric cancer

Scientific Title:Acronym

RDG for stage1 GC

Region

Japan


Condition

Condition

cStage1 gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of robot-assisted laparoscopic gastrectomy for patients with cStage1 gastric cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Incidence of grade 3 or more adverse event according to the Clavien-Dindo classification

Key secondary outcomes

Incidence of grade 2 or more adverse event according to the Clavien-Dindo classification, Completion rate of robot assisted laparoscopic surgery, Relapse-free survival


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

Robot assisted laparoscopic 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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically proven gastric adenocarcinoma and diagnosed as cStage1
2)Excluded from the indication of ESD
3)Body mass index of less than 30
4)Performance status of 0 or 1
5)Informed consent obtained from the patient

Key exclusion criteria

1)Previous laparotomy(excluding appendectomy and laparoscopic surgery)
2)Indication for emergency surgery
3)With active intestinal bleeding
4)With bowel obstruction
5)With Heart disease associated with symptoms(including unstable ungina or acute myocardial infarction or heart failure)
6)With pulmonary disease requiring continuous oxygen therapy
7)With uncontrolled diabetes mellitus
8)With uncontrolled hypertension
9)With Acute myocardial infarction in 6 months
10)With a history of previous deep thrombophlebitis or pulmonary embolism

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Eigo
Middle name None
Last name Otsuji

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5527

Email

otsuji@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name Kazuma
Middle name None
Last name Okamoto

Organization

Kyoto Prefectural University of Medicine

Division name

Division of Digestive Surgery

Zip code

602-8566

Address

465 Kajii-cho, Kamigyo-ku, Kyoto, Japan

TEL

075-251-5527

Homepage URL


Email

kazuma@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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

Kyoto Prefectural University of Medicine, Clinical Research Review Board

Address

465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

Tel

075-251-5337

Email

rinri@koto.kpu-m.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

京都府立医科大学附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2015 Year 10 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

2015 Year 07 Month 02 Day

Date of IRB

2014 Year 02 Month 28 Day

Anticipated trial start date

2015 Year 11 Month 01 Day

Last follow-up date

2024 Year 01 Month 10 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 07 Month 02 Day

Last modified on

2024 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021034


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name