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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015310
Receipt No. R000017808
Scientific Title A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Date of disclosure of the study information 2014/11/01
Last modified on 2019/07/26

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Basic information
Public title A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Acronym A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Scientific Title A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Scientific Title:Acronym A study of sentinel node navigation surgery for esophageal cancer and gastric cancer by radioisotope and blue dye.
Region
Japan

Condition
Condition Esophageal cancer/ Gastric cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the availability and safety of nodal evaluation of metastasis and individualized gastrectomy based on sentinel node biopsy for patients with cN0 esophageal cancer or gastric cancer .
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Accuracy of nodal evaluation of metastasis based on sentinel node biopsy.
Key secondary outcomes Number of identified SNs, Detection rate of sentinel nodes, sensitivity to detect lymph node metastasis based on sentinel node biopsy, negative predictive value of lymph node metastasis.

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 We use radioisotope and blue stain as a tracer, and perform SN mapping. We diagnose metastasis of SN by intraoperative and frozen tissue examination.
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) Age 20 to 80
2) Esophageal cancer or gastric cancer patients with no nodal metastasis nor distant metastasis.
3) Tumor with single lesion.
4) Provided with written informed conscent.
5) Histopathological results does not matter.
Key exclusion criteria 1) Pregnancy, severe drug allergy, asthoma.
2) Multiple tumor lesion or with synchronous or metachronous (within 5 years) malignancies.
3) With prior endoscopic treatment to same lesion.
4) Judged as irrelevant object for this study
5) Refusal of the trial entry
6) Absolute indication for endoscopic treatments
Target sample size 700

Research contact person
Name of lead principal investigator
1st name Yuko
Middle name
Last name Kitagawa
Organization Keio University, School of Medicine
Division name Department of Surgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email kitagawa@a3.keio.jp

Public contact
Name of contact person
1st name Kazumasa
Middle name
Last name Fukuda
Organization Keio University, School of Medicine
Division name Department of Surgery
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email fukudak@z6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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 160-8582, 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

Other administrative information
Date of disclosure of the study information
2014 Year 11 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 Terminated
Date of protocol fixation
2012 Year 10 Month 07 Day
Date of IRB
2012 Year 12 Month 21 Day
Anticipated trial start date
2012 Year 12 Month 21 Day
Last follow-up date
2018 Year 02 Month 16 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 10 Month 01 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=R000017808

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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