UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027649
Receipt number R000031679
Scientific Title A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Date of disclosure of the study information 2017/07/01
Last modified on 2018/09/04 09:44:55

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Basic information

Public title

A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer

Acronym

A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer

Scientific Title

A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer

Scientific Title:Acronym

A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer

Region

Japan


Condition

Condition

Gastric cander

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To demonstrate the safety and the curability of laparoscopic total gastrectomy for cStage II or III advanced gastric cancer compared with those open total gastrectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

anastomotic leakage, pancreatic fistula and intra-abdominal abscess

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Laparoscopic total 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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Histologically proven gastric adenocarcinoma.
2) Diagnosed cStage II or III by endoscopy and CT.
3) Tumor located in the upper third of the stomach, and curative resection is expected to be achievable by total gastrectomy.
4) Age: 20-90.
5) ECOG performance status 0-1.
6) Sufficient organ functions.
7) Written informed consent obtained from patients.

Key exclusion criteria

1) Pregnant or lactating female.
2) Patients with psychiatric disease or severe mental symptoms.
3) Patients with uncontrollable hypertension.
4) Patients with uncontrollable diabetes.
5) Other patients evaluated to be inadequate to participate in this study by investigators.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyuki Kojima

Organization

Tokyo Medical and Dental University

Division name

Center for minimally Invasive surgery

Zip code


Address

1-5-45 Yushima Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5803-5260

Email

k-kojima.srg2@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiro Tanioka

Organization

Tokyo Medical and Dental University Hospital

Division name

Department of Gastric Surgery

Zip code


Address

1-5-45 Yushima Bunkyo-ku, Tokyo, Japan

TEL

+81-3-5803-5260

Homepage URL


Email

tanioka.srg1@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental 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

2017 Year 07 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

Preinitiation

Date of protocol fixation

2017 Year 06 Month 06 Day

Date of IRB


Anticipated trial start date

2018 Year 08 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

2017 Year 06 Month 05 Day

Last modified on

2018 Year 09 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031679


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name