UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034781 |
|---|---|
| Receipt number | R000039658 |
| Scientific Title | A multi-institutional survey of treatment of esophago-aortic fistula after thoracic endovascular aortic repair: questionnaire results from the Japanese Esophageal Society. |
| Date of disclosure of the study information | 2019/03/31 |
| Last modified on | 2020/11/07 10:28:09 |
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Basic information
Public title
A multi-institutional survey of treatment of esophago-aortic fistula after thoracic endovascular aortic repair: questionnaire results from the Japanese Esophageal Society.
Acronym
Survey of treatment of esophago-aortic fistula after thoracic endovascular aortic repair.
Scientific Title
A multi-institutional survey of treatment of esophago-aortic fistula after thoracic endovascular aortic repair: questionnaire results from the Japanese Esophageal Society.
Scientific Title:Acronym
Survey of treatment of esophago-aortic fistula after thoracic endovascular aortic repair.
Region
| Japan |
Condition
Condition
Esophago-aortic fistula after thoracic endovascular aortic repair
Classification by specialty
| Gastrointestinal surgery | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment of esophago-aortic fistula after thoracic endovascular aortic repair and to clarify the efficacy of esophagectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference in survival period between patients underwent esophagectomy and those who did not.
Key secondary outcomes
Operative time, the number of doctors and nurses participated in the operation, and the incidence of postoperative complications
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 treatment for esophago-aortic fistula after thoracic endovascular aortic repair at the authorized institutes for board certificated esophageal surgery in Japan between January 2013 and December 2017.
Key exclusion criteria
nothing
Target sample size
200
Research contact person
Name of lead principal investigator
| 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
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
39
Results
The survival rate in patients who underwent esophagectomy was higher than in those who did not. The survival of patients who underwent both esophagectomy and aortic replacement was also higher than in those who did not.
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 institutes at Authorized Institutes for Board Certified Esophageal Surgeons. Thirty-nine patients with AEF developed after TEVAR were identified from 15 institutes.
Participant flow
The Japan Esophageal Society conducted a questionnaire survey targeting authorized or semi-authorized institutes at Authorized Institutes for Board Certified Esophageal Surgeons. Thirty-nine patients with AEF developed after TEVAR were identified from 15 institutes.
Adverse events
Postoperative complications were observed in 24 patients. Complications Grade III or higher were observed in 53.1% of patients. Operative and hospital mortality rates were 3.1% and 18.8%, respectively.
Outcome measures
The survival rate in patients who underwent esophagectomy was higher than in those who did not (P？<？0.0001). The survival of patients who underwent both esophagectomy and aortic replacement was also higher than in those who did not (P？<？0.0001).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 02 | Month | 23 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 23 | Day |
Other
Other related information
The results of this study has been published in the Esophagus (2020; 17: 81-86).
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=R000039658
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