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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034781
Receipt No. 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 2018/11/06

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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
Middle name
Last name Masayuki Watanabe
Organization Cancer Institute Hospital of Japanese Foundation for Cancer Research
Division name Department of Gastroenterological Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Email masayuki.watanabe@jfcr.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Watanabe
Organization Cancer Institute hospital of Japanese foundation for Cancer Research
Division name Department of Gastroenterological Surgery
Zip code
Address 3-8-31 Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email masayuki.watanabe@jfcr.or.jp

Sponsor
Institute Japan Esophageal Society
Institute
Department

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
Address
Tel
Email

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
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 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
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The results of this study will be published in the Esophagus.

Management information
Registered date
2018 Year 11 Month 06 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039658

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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