UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011451
Receipt number R000013405
Scientific Title Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter
Date of disclosure of the study information 2013/08/13
Last modified on 2013/08/13 12:32:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter

Acronym

Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter

Scientific Title

Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter

Scientific Title:Acronym

Comparison of surgical stress between transthoracic and video-assisted thoracoscopic esophagectomy for esophageal cancer by indirect calorimeter

Region

Japan


Condition

Condition

Thoracic esophageal cancer

Classification by specialty

Surgery in general Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To prove minimal invasiveness of video-assisted thoracoscopic esophagectomy than transthoracic esophagectomy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

resting energy expenditure,
non-protein respiratory quotient

Key secondary outcomes



Base

Study type


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

video-assisted thoracoscopic esophagectomy and lymph node dissection

Interventions/Control_2

transthoracic esophagectomy and lymph node dissection

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)Written informed consent : Patients capable of providing written consent by themselves after full explanation of the study details using written information to patients.
(2)Patients that esophagectomy for esophageal cancer is performed.

Key exclusion criteria

Patients whom doctor judged to be ineligible for this study.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiyoshi Fujiwara

Organization

Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

Division name

Gastroenterological Surgery

Zip code


Address

2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan

TEL

086-235-7257

Email



Public contact

Name of contact person

1st name
Middle name
Last name Naoaki Maeda

Organization

Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

Division name

Gastroenterological Surgery

Zip code


Address

2-5-1,Shikata-cho,Kita-ku,Okayama-shi,Japan

TEL

086-235-7257

Homepage URL


Email

p41n53io@cc.okayama-u.ac.jp


Sponsor or person

Institute

Gastroenterological Surgery
Okayama University Graduate School of Medicine,Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

none

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


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

2013 Year 08 Month 13 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

Open public recruiting

Date of protocol fixation

2013 Year 05 Month 29 Day

Date of IRB


Anticipated trial start date

2013 Year 05 Month 29 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 08 Month 11 Day

Last modified on

2013 Year 08 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name