UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040909 |
|---|---|
| Receipt number | R000046702 |
| Scientific Title | Study of treatment for esophageal cancer |
| Date of disclosure of the study information | 2020/06/26 |
| Last modified on | 2020/06/26 05:10:04 |
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Basic information
Public title
Study of treatment for esophageal cancer
Acronym
Study of treatment for esophageal cancer
Scientific Title
Study of treatment for esophageal cancer
Scientific Title:Acronym
Study of treatment for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study was to assess the feasibility,complications,and morbidity of TPLE with MIE.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative complication and prognosis
Key secondary outcomes
none
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
patients who underwent surgery for esophageal cancer from Jan 1997 to Dec 2018 received TPLE with gastric tube reconstruction via thoracoscopy.
Key exclusion criteria
thoracotomy, mediastinal endoscopy
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mori |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1 Maidashi, Fukuoka
TEL
+81-92-642-5466
m_mori@surg2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasue |
| Middle name | |
| Last name | Kimura |
Organization
Graduate School of Medical Sciences,Kyushu University
Division name
Department of Surgery and Science
Zip code
812-8582
Address
3-1-1 Maidashi, Fukuoka
TEL
+81-92-642-5466
Homepage URL
yasuek@surg2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences,Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical Sciences,Kyushu University
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
Hospital ethical review committee
Address
3-1-1 Maidashi, Fukuoka
Tel
3-1-1 Maidashi, Fukuoka
ijkseimei@jimu.kyushu-u.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
九州大学大学院消化器総合外科
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 26 | 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
26
Results
Results date posted
| 2020 | Year | 06 | Month | 25 | Day |
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
Completed
Date of protocol fixation
| 2019 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective study
Management information
Registered date
| 2020 | Year | 06 | Month | 26 | Day |
Last modified on
| 2020 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046702
