UMIN-CTR Clinical Trial

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034782
Receipt No. 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 (Ver. 4)

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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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039660