UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015818
Receipt number R000018409
Scientific Title Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer
Date of disclosure of the study information 2014/12/02
Last modified on 2019/09/19 16:27:16

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Basic information

Public title

Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer

Acronym

Robotic assisted esophagectomy

Scientific Title

Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer

Scientific Title:Acronym

Robotic assisted 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 determine the efficacy and safety of robotic assisted thoracoscopic esophagectomy with reconstruction for esophageal cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Intraoperative blood loss
Duration of operation
Number of harvested lymph node

Key secondary outcomes

Length of postoperative hospital stay
Postoperative course
Postoperative complication
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

Uncontrolled

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

Robotic assisted thoracoscopic subtotal esophagectomy with reconstruction for esophageal cancer was performed from approval to 31st, Dec/2019.

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

Esophageal cancer indicated for thoracoscopic esophagectomy

Key exclusion criteria

T4 tumors (Tumors invades adjacent structures)

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Satoru
Middle name
Last name Motoyama

Organization

Akita University Hospital

Division name

Esophageal Surgery

Zip code

0108543

Address

1-1-1 Hondo, Akita

TEL

0188846132

Email

motoyama@doc.med.akita-u.ac.jp


Public contact

Name of contact person

1st name Satoru
Middle name
Last name Motoyama

Organization

Akita University Hospital

Division name

Esophageal Surgery

Zip code

0108543

Address

1-1-1 Hondo, Akita

TEL

0188846132

Homepage URL


Email

motoyama@doc.med.akita-u.ac.jp


Sponsor or person

Institute

Akita University Hospital

Institute

Department

Personal name



Funding Source

Organization

Akita University Hospital

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

Akita University Hospital

Address

1-1-1 Hondo, Akita

Tel

0188341111

Email

soken@hos.akita-u.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

2014 Year 12 Month 02 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

13

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

Completed

Date of protocol fixation

2014 Year 12 Month 02 Day

Date of IRB

2014 Year 10 Month 14 Day

Anticipated trial start date

2014 Year 12 Month 02 Day

Last follow-up date

2023 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

2014 Year 12 Month 02 Day

Last modified on

2019 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018409


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name