UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007450
Receipt number 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 2022/03/14 21:04:39

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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 or person

Institute

the University of Tokyo Hospital

Institute

Department

Personal name



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

Value
https://center6.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