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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029317
Receipt No. R000033516
Scientific Title Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Date of disclosure of the study information 2017/10/01
Last modified on 2018/10/01

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Basic information
Public title Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Acronym Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Scientific Title Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Scientific Title:Acronym Single-arm feasibility study of laparoscopic distal gastrectomy for advanced gastric cancer to verify the safety of proximal margins
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the equality in terms of proximal margins in LDG against open distal gastrectomy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proximal margins
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Perform laparoscopic distal gastrectomy for patients diagnosed as cT1N2-3, cT2N1-4, cT3N0, or cT4aN0 gastric cancer.
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) Pathologically diagnosed as gastric cancer
2) Diagnosed as cT1N2-3, cT2N1-3, cT3N0, cT4aN0 (except bulky N2), cM0 by preoperative imaging studies
3) Age 20 to 80
4) PS(ECOG)0 to 2
5) Patients without history of treatment for gastric cancer
6) BMI under 30
7) Patient's approval
Key exclusion criteria 1) Patients with synchronous double cancer, metachronous double cancer (within 5 years) (except carcinoma in situ).
2) Patients with cT4b, cM1 gastric cancer
3) Patients who went under preoperative treatment for gastric cancer (except staging laparoscopy).
4) Patients with possibility of pregnancy.
5) Patients with mental disorder who are difficult to participate in the study.
6) Patients who are recieving steroid therapy.
7) Patients with viral, bacterial, and fungal infections who requires medical treatment.
8) Patients with poorly controlled diabetes.
9) Patients with unstable angina or myocardial infarction
10) Patients with respiratory disorder who requires oxygen inhalation.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoki Hiki
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Department Gastroenterological Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL 03-3520-0111
Email naoki.hiki@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiaki Shoji
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name Department Gastroenterological Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan
TEL 03-3520-0111
Homepage URL
Email yoshiaki.shoji@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department

Funding Source
Organization Cancer Institute Hospital, Japanese Foundation for Cancer Research
Organization
Division
Category of Funding Organization Non profit foundation
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 YES
Study ID_1 2017-1049
Org. issuing International ID_1 Cancer Institute Hospital, Japanese Foundation for Cancer Research
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 10 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 09 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 10 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 09 Month 27 Day
Last modified on
2018 Year 10 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033516

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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