UMIN-CTR Clinical Trial

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	2011 Year 09 Month 22 Day
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	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 03 Month 05 Day
Last modified on	2022 Year 03 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008769