UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of the safety and the curability of laparoscopic total gastrectomy for advanced gastric cancer
Title of the study (Brief title)	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	Kazuyuki Kojima
Organization	Tokyo Medical and Dental University
Division name	Center for minimally Invasive surgery
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	Toshiro Tanioka
Organization	Tokyo Medical and Dental University Hospital
Division name	Department of Gastric Surgery
Address	1-5-45 Yushima Bunkyo-ku, Tokyo, Japan
TEL	+81-3-5803-5260
Homepage URL
Email	tanioka.srg1@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031679