UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034782 |
|---|---|
| Receipt number | R000039660 |
| Scientific Title | Multi-institutional survey of thoracic endovascular aortic repair for patients with esophageal cancer |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2020/11/07 10:44:35 |
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Basic information
Public title
Multi-institutional survey of thoracic endovascular aortic repair for patients with esophageal cancer
Acronym
Thoracic endovascular aortic repair for esophageal cancer
Scientific Title
Multi-institutional survey of thoracic endovascular aortic repair for patients with esophageal cancer
Scientific Title:Acronym
Thoracic endovascular aortic repair for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Gastrointestinal surgery | Vascular surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of thoracic endovascular aortic repair for esophageal cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The survival period after thoracic endovascular aortic repair for bleeding due to esophageal cancer with aortic invasion
The postoperative survival period after esophagectomy following thoracic endovascular aortic repair
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent thoracic endovascular aortic repair for esophageal cancer at the authorized institutes for board certificated esophageal surgery between January 2013 and December 2017.
Key exclusion criteria
nothing
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Masayuki |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
0335200111
masayuki.watanabe@jfcr.or.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Watanabe |
Organization
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name
Department of Gastroenterological Surgery
Zip code
135-8550
Address
3-8-31 Ariake, Koto-ku, Tokyo
TEL
0335200111
Homepage URL
https://www.jfcr.or.jp/hospital/examination/research/publish.html
masayuki.watanabe@jfcr.or.jp
Sponsor or person
Institute
Japan Esophageal Society
Institute
Department
Personal name
Funding Source
Organization
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
Japanese Foundation for Cancer Research
Address
3-8-31 Ariake, Koto-ku, Tokyo
Tel
0335200111
med.shinsa@jfcr.or.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.jfcr.or.jp/hospital/examination/research/publish.html
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10388-019-00683-y
Number of participants that the trial has enrolled
41
Results
The median survival time after TEVAR was 135 days in the hemorrhage or impending hemorrhage group and 378 days in the preoperative prophylaxis group. Eighteen patients underwent esophagectomy after TEVAR. No hemorrhagic event was observed during the perioperative period. The median survival time of the patients who underwent esophagectomy was 373 days.
Results date posted
| 2020 | Year | 11 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The Japan Esophageal Society conducted a questionnaire survey targeting authorized or semi-authorized member institutes of the Authorized Institutes for Board Certified Esophageal Surgeons. Patients who underwent TEVAR for esophageal cancer were identified from 19 institutes.
Participant flow
The Japan Esophageal Society conducted a questionnaire survey targeting authorized or semi-authorized member institutes of the Authorized Institutes for Board Certified Esophageal Surgeons. Patients who underwent TEVAR for esophageal cancer were identified from 19 institutes.
Adverse events
No hemorrhagic event was observed during the perioperative period.
Outcome measures
Overall Survival
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results of thios study have been published in the Esophagus (2020; 17: 74-80).
Management information
Registered date
| 2018 | Year | 11 | Month | 06 | Day |
Last modified on
| 2020 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039660
