UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011451
Receipt No. 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

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

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
URL(English) https://upload.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


Contact us.