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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010154
Receipt No. R000011891
Scientific Title The efficacy of the sentinel node navigation surgery for early gastric cancer
Date of disclosure of the study information 2013/03/04
Last modified on 2019/09/07

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Basic information
Public title The efficacy of the sentinel node navigation surgery for early gastric cancer
Acronym SNNS for EGC
Scientific Title The efficacy of the sentinel node navigation surgery for early gastric cancer
Scientific Title:Acronym SNNS for EGC
Region
Japan

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

Objectives
Narrative objectives1 The effectiveness and disadvantage of the sentinel node navigation surgery for early gastric cancer will be investigated in comparison with the surgery according to the Japanese guideline. In this observational study, the patients suffered from early gastric cancer will be performed limited surgery with a tailored lymph node dissection if they are diagnosed negative for nodal metastasis using the intraoperative sentinel node biopsy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes The occurrence rate of the postoperative morbidity
Key secondary outcomes The occurrence rate of the postoperative symptoms
Disease free survival
Overall survival
Rate of the metachronous multiple gastric cancers
Parameters of the surgery between the surgical procedures

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 The patients suffered from early gastric cancer will be performed sentinel node biopsy using ICG fluorescent method. The candidate of the sentinel nodes will be send to the pathological section for intraoperative rapid diagnosis. If the patient will be diagnosed as node positive, he will be performed standard gastric resection with lymph node dissection up to D2 according to the Japanese Guideline. If the patient will be diagnosed as node negative, he will be performed limited surgery with a tailored lymph node dissection. We call this strategy as the sentinel node navigation surgery.
The effectiveness and disadvantage of the sentinel node navigation surgery will be investigated in comparison with the data of the patients of our institute in the past that were performed sentinel node biopsy and standard gastrectomy according to the Japanese guideline.
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Having gastric cancer confirmed by the endoscopic biopsy
2) Over 20 years old
3) ECOG performance status 0-1
4) Tolerable for general anesthesia and gastric surgery
5) No preoperative chemotherapy for gastric cancer
6) cT1 cancer out of indication of EMR/ESD, or superficial cT2 cancer
7) Single cancer less than 4 cm in a diameter
8) cN0 diagnosed in preoperative X-CT
Key exclusion criteria 1) Having synchronous multiple gastric cancer
2) Having marked fibrosis caused by intractable gastric ulcer
3) Treating with huge dose of steroid
4) Having uncontrolled diabetes mellitus
5) Having severe drug allergy or bronchial asthma
6) Having intractable liver cirrhosis
7) Having psychological disorder and difficulty in decision by their own will
8) Other reasons considered by the investigator
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Takeo
Middle name
Last name Kosaka
Organization Kanazawa Medical University
Division name Department of surgical oncology
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan
TEL 0762862211
Email tkosaka@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name Shinichi
Middle name
Last name Kinami
Organization Kanazawa Medical University
Division name Department of surgical oncology
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan
TEL 0762862211
Homepage URL
Email kinami@kanazawa-med.ac.jp

Sponsor
Institute Department of surgical oncology, Kanazawa Medical University
Institute
Department

Funding Source
Organization Department of surgical oncology, Kanazawa Medical University
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 Kanazawa Medical University
Address 1-1 Daigaku, Uchinada, Kahoku, Ishikawa, Japan
Tel 0762862211
Email kinami@kanazawa-med.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 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 04 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
2013 Year 01 Month 31 Day
Date of IRB
2013 Year 03 Month 04 Day
Anticipated trial start date
2013 Year 03 Month 04 Day
Last follow-up date
2023 Year 03 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
2013 Year 03 Month 03 Day
Last modified on
2019 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011891

Research Plan
Registered date File name
2016/09/04 SNNS試験実施計画書20130308修正版.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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