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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027649
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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