UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016876 |
|---|---|
| Receipt number | R000019590 |
| Scientific Title | A study to evaluate mediastinoscopic esophagectomy for esophageal cancer |
| Date of disclosure of the study information | 2015/03/23 |
| Last modified on | 2019/09/25 18:22:30 |
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Basic information
Public title
A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Acronym
A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Scientific Title
A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Scientific Title:Acronym
A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate curability of patients for esophageal cancer undergoing mediastinoscopic esophagectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dissection level of mediastinal lymph nodes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Mediastinoscopic esophagectomy
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) patients histlogically confirmed esophageal cancer
2) patients planning to undergo esophagectomy and reconstruction using gastric tube
3) patients written informed concent
Key exclusion criteria
1) patients with severe liver disease, renal disease, heart disease, and so on
2) pregnancy
3) patients judged inadequate to this study by chief doctor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Tokairin |
Organization
Tokyo Medical and Dental University
Division name
Dept. Gastrointestinal Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5254
tokairin.srg1@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Tokairin |
Organization
Tokyo Medical and Dental University
Division name
Dept. Gastrointestinal Surgery
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5254
Homepage URL
tokairin.srg1@tmd.ac.jp
Sponsor or person
Institute
Dept. Dept. Gastrointestinal Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Dept. Dept. Gastrointestinal Surgery, Tokyo Medical and Dental 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
Independent Ethics Committee of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-5096
t_inoue.adm@tmd.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
| 2015 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 08 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 12 | 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
| 2015 | Year | 03 | Month | 23 | Day |
Last modified on
| 2019 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019590
