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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014401
Receipt No. R000011295
Scientific Title A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Date of disclosure of the study information 2014/06/27
Last modified on 2019/07/26

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Basic information
Public title A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Acronym A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Scientific Title A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Scientific Title:Acronym A study of Sentinel Node Navigation Surgery for Early Gastric Cancer
Region
Japan

Condition
Condition Clinically T1N0 gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the availability and safety of the individuarized gastrectomy based on sentinel node concept for the early gastric cancer
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Postoperative 5-year recurrence free survival(RFS) ratio
Key secondary outcomes postoperative 3-year RFS rate, postoperative 3/5-year overall survival, sentinel node detection rate, distribution, sensitivity, accuracy for lymph node metastases, quality of life after surgery

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Minimized gastrectomy and sentinel basin resection group :
for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread within the confines of the resection range of minimized surgery.
Interventions/Control_2 Conventional gastrectomy and sentinel basin resection group :
for the patients whose sentinel nodes were negative by intraoperative pathological diagnosis and spread beyond the confines of the resection range of minimized surgery.
Interventions/Control_3 Conventional gastrectomy group :
for the patients whose sentinel nodes were positive by intraoperative pathological diagnosis.
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) Clinically diagnosed T1N0 early gastric cancer
2) Single lesion
3) Less than 40mm in size
4) Provided written informed concent
5) Histopathological type does not matter
Key exclusion criteria 1) Pregnancy, severe drug allergy, asthoma.
2) Multiple lesion
3) With prior treatment to same lesion
4) Synchronous or metachronous (within 5 years) malignancies.
5) Judged as irrelevant object for this study
6) Refusal of the trial entry
7) Remnant gastric cancer
8) Absolute indication for endoscopic treatments
Target sample size 225

Research contact person
Name of lead principal investigator
1st name Hirofumi
Middle name
Last name Kawakubo
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email hkawakubo@z3.keio.jp

Public contact
Name of contact person
1st name Hirofumi
Middle name
Last name Kawakubo
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email hkawakubo@z3.keio.jp

Sponsor
Institute School of Medicine, Keio 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 Keio University School of Medicine, Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.jp

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 鹿児島大学医学部・歯学部附属病院(鹿児島県)、国立大学法人三重大学医学部附属病院(三重県)、岩手医科大学附属病院(岩手県)、東京医科大学病院(東京都)、石川県立中央病院(石川県)、千葉大学医学部附属病院(千葉県)、防衛医科大学校病院(埼玉県)、公立大学法人福島県立医科大学附属病院(福島県)、金沢大学附属病院(石川県)、東海大学医学部附属病院(神奈川県)、埼玉メディカルセンター(埼玉県)、東京慈恵会医科大学附属病(東京都)、東京慈恵会医科大学附属柏病院(千葉県)、金沢医科大学(石川県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 27 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 Terminated
Date of protocol fixation
2013 Year 09 Month 01 Day
Date of IRB
2014 Year 05 Month 26 Day
Anticipated trial start date
2014 Year 05 Month 26 Day
Last follow-up date
2025 Year 05 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2019 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011295

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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