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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016876
Receipt No. R000019590
Scientific Title A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Date of disclosure of the study information 2015/03/23
Last modified on 2019/09/25

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Basic information
Public title A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Acronym A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Scientific Title A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Scientific Title:Acronym A study to evaluate mediastinoscopic esophagectomy for esophageal cancer
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate curability of patients for esophageal cancer undergoing mediastinoscopic esophagectomy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Dissection level of mediastinal lymph nodes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Mediastinoscopic esophagectomy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients histlogically confirmed esophageal cancer
2) patients planning to undergo esophagectomy and reconstruction using gastric tube
3) patients written informed concent
Key exclusion criteria 1) patients with severe liver disease, renal disease, heart disease, and so on
2) pregnancy
3) patients judged inadequate to this study by chief doctor
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Tokairin
Organization Tokyo Medical and Dental University
Division name Dept. Gastrointestinal Surgery
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5254
Email tokairin.srg1@tmd.ac.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Tokairin
Organization Tokyo Medical and Dental University
Division name Dept. Gastrointestinal Surgery
Zip code 113-8510
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
TEL 03-5803-5254
Homepage URL
Email tokairin.srg1@tmd.ac.jp

Sponsor
Institute Dept. Dept. Gastrointestinal Surgery, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Dept. Dept. Gastrointestinal Surgery, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Independent Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo
Tel 03-5803-5096
Email t_inoue.adm@tmd.ac.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
2015 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 02 Month 08 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 24 Day
Date of IRB
2015 Year 02 Month 24 Day
Anticipated trial start date
2015 Year 03 Month 23 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2019 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019590

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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