UMIN-CTR Clinical Trial

Recruitment status Completed
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 2020/11/07 (Ver. 4)

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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
Email 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
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 Japanese Foundation for Cancer Research
Address 3-8-31 Ariake, Koto-ku, Tokyo
Tel 0335200111
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039658