UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015388
Receipt number R000017904
Scientific Title Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study
Date of disclosure of the study information 2014/10/10
Last modified on 2014/10/09 18:02:14

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Basic information

Public title

Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study

Acronym

Robotic gastrectomy for gastric cancer

Scientific Title

Feasibility, safety, effectiveness, and economical efficiency of robotic gastrectomy for resectable gastric cancer: a multi-institutional historically controlled prospective cohort study

Scientific Title:Acronym

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

Morbidity

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Postoperative complications greater than Grade III according to Clavien-Dindo classification

Key secondary outcomes

Postoperative Complications grater than Grade II according to Clavien-Dindo classification,
Health outcomes measured by EuroQol 5 Dimension (EQ-5D)
Total Medical Cost
Disease free survival
Robotic gastrectomy success rate
Conversion to laparotomy
Intraoperative adverse effects
Surgical outcomes
Postoperative courses
Surgery-Related Mortality


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

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 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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Operable patients under general anesthesia
Histologically diagnosed gastric adenocarcionoma
cStage I or II disease curably treated with total, distal, or proximal gastrectomy with D1+ or D2 lymph node dissection
Not indicated for endoscopic resection
Age over 18
Informed consent is obtained

Key exclusion criteria

Patients with mental disorders
Preoperative use of chemotherapy

Target sample size

330


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ichiro Uyama

Organization

Fujita Health University

Division name

Division of Upper GI, Department of Surgery

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan

TEL

0562-93-9254

Email

iuyama@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazuharu Hamano

Organization

Fujita Health University Hospital

Division name

Medical office worker

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi 470-1192, Japan

TEL

0562-93-2025

Homepage URL


Email

hamano@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2014 Year 10 Month 10 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

Open public recruiting

Date of protocol fixation

2014 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 10 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

2014 Year 10 Month 09 Day

Last modified on

2014 Year 10 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017904


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name