UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015310 |
|---|---|
| Receipt number | 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 14:25:58 |
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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
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
fukudak@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017808
