UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011642 |
|---|---|
| Receipt number | R000013596 |
| Scientific Title | Prospective study of thoracoscopic esophagectomy with rigid and flexible video-endoscope |
| Date of disclosure of the study information | 2013/09/18 |
| Last modified on | 2013/09/03 20:21:26 |
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Basic information
Public title
Prospective study of thoracoscopic esophagectomy with rigid and flexible video-endoscope
Acronym
Prospective study of thoracoscopic esophagectomy about video-endoscope
Scientific Title
Prospective study of thoracoscopic esophagectomy with rigid and flexible video-endoscope
Scientific Title:Acronym
Prospective study of thoracoscopic esophagectomy about video-endoscope
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety study of thoracoscopic esophagectomy with rigid and flexible video-endoscope
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
completion rate
Key secondary outcomes
background, operation time, amount of bleeding, amount of lymph node dissection, durability
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
flexible video-endoscope
Interventions/Control_2
rigid video-endoscope
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
Elibible for thoracoscopic esophagectomy in prone position
Key exclusion criteria
Ineligible for thoracoscopic esophagectomy in prone position
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Shirakawa |
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
TEL
086-235-7257
yasuwr@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiaki Ohara |
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
TEL
086-235-7257
Homepage URL
carib2@msj.biglobe.ne.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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 | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | 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 | 03 | Day |
Last modified on
| 2013 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013596
