UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011451 |
|---|---|
| Receipt number | R000013405 |
| Scientific Title | Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter |
| Date of disclosure of the study information | 2013/08/13 |
| Last modified on | 2013/08/13 12:32:01 |
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Basic information
Public title
Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter
Acronym
Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter
Scientific Title
Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter
Scientific Title:Acronym
Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter
Region
| Japan |
Condition
Condition
Thoracic esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove minimal invasiveness of video-assisted thoracoscopic esophagectomy than transthoracic esophagectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
resting energy expenditure,
non-protein respiratory quotient
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Written informed consent : Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2)Patients that esophagectomy for esophageal cancer is performed.
Key exclusion criteria
Patients whom doctor judged to be ineligible for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyoshi Fujiwara |
Organization
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name
Gastroenterological Surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL
086-235-7257
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoaki Maeda |
Organization
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Division name
Gastroenterological Surgery
Zip code
Address
2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan
TEL
086-235-7257
Homepage URL
p41n53io@cc.okayama-u.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
none
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 | 08 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 29 | 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 | 08 | Month | 11 | Day |
Last modified on
| 2013 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013405
