UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011660 |
|---|---|
| Receipt number | R000013630 |
| Scientific Title | Sentinel node navigation with CT lymphography in esophageal cancer patients |
| Date of disclosure of the study information | 2013/09/09 |
| Last modified on | 2018/08/28 06:41:23 |
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Basic information
Public title
Sentinel node navigation with CT lymphography in esophageal cancer patients
Acronym
CT lymphography in esophageal cancer patients
Scientific Title
Sentinel node navigation with CT lymphography in esophageal cancer patients
Scientific Title:Acronym
CT lymphography in esophageal cancer patients
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical utility of CT lymphography in sentinel lymph node detection in esophageal cancer patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preoperative detection rate of sentinel node
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
CT lymphography
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
No evident lymph node metastasis or distant metastasis
Solitary lesion
Histologically diagnosed as esophageal cancer
Key exclusion criteria
Pregnant woman
Past histry of iodine allergy, asthma
Mutiple lesions
Previously treated with endoscopy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kitagawa |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
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 | |
| Middle name | |
| Last name | Hiroya Takeuchi |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Homepage URL
htakeuchi@a6.keio.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, 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
Address
Tel
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
| 2013 | Year | 09 | Month | 09 | 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 | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 05 | Day |
Last modified on
| 2018 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013630
