UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000021244