UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018350
Receipt number R000021244
Scientific Title The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer
Date of disclosure of the study information 2015/07/19
Last modified on 2020/01/21 20:14:44

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Basic information

Public title

The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer

Acronym

The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer

Scientific Title

The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer

Scientific Title:Acronym

The study of efficacy and safety of laparoscopic gastrectomy for Stage II,III advanced gastric cancer

Region

Japan


Condition

Condition

Gastric cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Inspection of efficacy and safety of laparoscopic gastrectomy for advanced gastric cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Overall survival

Key secondary outcomes

Achievemnt rate
Background
Procedure
Operation time
Blood loss
Intraoperative complication
Postoperative complication
Postoperative chemotherapy


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

Surgery

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 carcinoma
2) MP,SS or deeper lesion without involvement of other organs, N0-2 excluding bulky N2 and M0 according to the Japanese classification system
3) tumor located in the upper, body and antrum of the stomach and indication for total or distal gastrectomy
4)No invasion to duodenum
5) Aged 20 to 80 year
6) PS (ECOG)0 or 1
7) Body mass index < 30
8) no history of gastrointestinal surgery
9) no history of chemotherapy or radiotherapy
10) Sufficient organ functions
11) provided written informed consent

Key exclusion criteria

1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ.
2)Women during pregnancy or breast-feeding.
3)Severe mental disease.
4) Continuous systemic steroid therapy.
5)History of myocardial infarction or unstable angina pectoris within six months.
6)Uncontrollable hypertension.
7)Uncontrollable diabetes millutus or administration of insulin.
8)Severe respiratory disease requiring continuous oxygen therapy.
9)Severe adhesion.
10)Severe circulative disfunction.
11)No resection.
12)The person in charge judges as an inappropriate case.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Akinibu
Middle name
Last name Taketomi

Organization

Hokkaido University

Division name

Gastroenterological Surgery I

Zip code

060-8638

Address

N15, W7, kita-ku, Sapporo, Japan

TEL

011-706-5927

Email

taketomi@med.hokudai.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name Yoshida

Organization

Hokkaido University

Division name

Gastroenterological Surgery I

Zip code

060-8638

Address

N15, W7, kita-ku, Sapporo, Japan

TEL

011-706-5927

Homepage URL


Email

ta73825@dg7.so-net.ne.jp


Sponsor or person

Institute

Gastroenterological Surgery I, Hokkaido University

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

Hokkaido University

Address

N15, W7, kita-ku, Sapporo, Japan

Tel

011-706-7636

Email

none


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

2015 Year 07 Month 19 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

Enrolling by invitation

Date of protocol fixation

2015 Year 07 Month 13 Day

Date of IRB

2015 Year 08 Month 01 Day

Anticipated trial start date

2015 Year 08 Month 01 Day

Last follow-up date

2021 Year 07 Month 31 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 19 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021244


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name