UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016403 |
|---|---|
| Receipt number | R000019052 |
| Scientific Title | To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country |
| Date of disclosure of the study information | 2015/01/31 |
| Last modified on | 2018/08/30 10:46:04 |
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Basic information
Public title
To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Acronym
To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Scientific Title
To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Scientific Title:Acronym
To assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
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 assess the safety and establish the risk model of thoracoscopic esophagectomy in our country
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative morbidity rate
mortality rate within 30 days
inhospital mortality rate
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
video-assisted thoracoscopic esophagectomy and lymph node dissection
Interventions/Control_2
transthoracic esophagectomy and lymph node dissection
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing esophagectomy and enrolled to NCD datebase in 2011 and 2012.
Key exclusion criteria
Patients whose doctor judged to be ineligible for this study.
Target sample size
3500
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
03-3353-6440
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
03-3353-6440
Homepage URL
htakeuchi@a6.keio.jp
Sponsor or person
Institute
The Japan Esophageal Society
Institute
Department
Personal name
Funding Source
Organization
The Japan Esophageal Society
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 01 | Month | 31 | 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
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
Main results already published
Date of protocol fixation
| 2013 | Year | 04 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 31 | 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
| 2015 | Year | 01 | Month | 31 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019052
