UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010154 |
|---|---|
| Receipt number | 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 10:04:40 |
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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
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
kinami@kanazawa-med.ac.jp
Sponsor or person
Institute
Department of surgical oncology, Kanazawa Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011891
