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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007450
Receipt No. R000008769
Scientific Title Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer
Date of disclosure of the study information 2012/03/06
Last modified on 2015/04/06

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Basic information
Public title Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer
Acronym Robotic assisted transhiatal radical esophagectomy
Scientific Title Robotic assisted mediatinoscopic subtotal esophagectomy and three-field dissection for esophageal cancer
Scientific Title:Acronym Robotic assisted transhiatal radical esophagectomy
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To establish a radical surgery without thoracotomy for esophageal cancer by applying a robotic surgery system (da Vinci S) for mediastinoscopic operative field.
To demonstrate the safety, oncological equality and minimal invasiveness of the newly developed surgery compared to the comventional surgery
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes intraoperative blood loss
duration of operation
surgical morbidity
Key secondary outcomes number of harvested lymph nodes
length of postoperative hospital stay
disease free survival

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 From approval to the 31st, March/2014
Non thoracic, transhiatal esophagectomy with three-field radical lymphadenectomy for esophageal cancer
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Curable thoracic esophageal and/or gastroesophageal junctional cancer
Key exclusion criteria Tumor invading adjacent organ
Prior chemoradiotherapy
Abnormal laboratory findings (CRP>10,WBC>15000)
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuyuki Seto
Organization the University of Tokyo Hospital
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1Hongo, Bunkyo-ku Tokyo,JPN
TEL 03-3815-5411
Email seto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiko Mori
Organization the University of Tokyo Hospital
Division name Gastrointestinal Surgery
Zip code
Address 7-3-1Hongo, Bunkyo-ku Tokyo
TEL 03-3815-5411
Homepage URL
Email morikaz158@gmail.com

Sponsor
Institute the University of Tokyo Hospital
Institute
Department

Funding Source
Organization the University of Tokyo Hospital
Organization
Division
Category of Funding Organization
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
2012 Year 03 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/dote.12345/full
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 No longer recruiting
Date of protocol fixation
2011 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
2016 Year 03 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
2012 Year 03 Month 05 Day
Last modified on
2015 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008769

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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