UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018242 |
|---|---|
| Receipt number | R000020951 |
| Scientific Title | Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer |
| Date of disclosure of the study information | 2015/07/09 |
| Last modified on | 2020/07/12 22:16:06 |
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Basic information
Public title
Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Acronym
Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Scientific Title
Safety and efficacy of Video-Assisted Thoracoscopic Surgery for Esophageal cancer
Scientific Title:Acronym
Safety and efficacy of Video-Assisted Thoracoscopic Surgery 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 the efficacy and safety of Video-Assisted Thoracoscopic operation for patients with esophageal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The harmful case that occurred within 30 days after the operation
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
Video-Assisted Thoracoscopic operation
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
1. Histological diagnosis as the esophageal cancer
2. Esophageal lesion is in the thoracic esophagus (UICC-TNM 7th edition)
3. Single or multiple esophageal lesions
4. cT1-3, N0 (UICC 7th edition)
5. Aged over 20 years and under 80 years at the time of registration
6. Performance Status(ECOG):0 or 1
7. Previously not treated for esophageal cancer (Diagnosed as ycT1-3, N0 after the preoperative chemotherapy)
8. Previously not treated chemotherapy or radiotherapy for other cancers.
9. Previously not treated for the right side of body with the thoracotomy. (incl. thoracoscopic surgery)
10. Adequate organ function
11. Written IC
Key exclusion criteria
1. Tumor progress range: T4 (UICC 7th edition)
2. The central of lesion is at the esophago-gastric junction rather than the anal side.
3. Serious organ derangements
4. Serious active infections
5. Serious complications
6. Pregnant, lactating or women of child-bearing potential.
7. The patient is judged unsuitable for the subject of this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sohda |
Organization
Gunma University Hospital
Division name
Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8224
msohda@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sohda |
Organization
Gunma University Hospital
Division name
Integrative Center of General Surgery
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma 371-8511
TEL
027-220-8224
Homepage URL
msohda@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University Hospital
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
| 2015 | Year | 07 | Month | 09 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 05 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2020 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020951
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
