UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000018350
Receipt No. 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

* 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 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
Institute Gastroenterological Surgery I, Hokkaido University
Institute
Department

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
URL(English) https://upload.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


Contact us.