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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000006062
Receipt No. R000007176
Scientific Title The relation of cytokine concentration in epithelial lining fluid and in peripheral blood HLA-DR during esophagectomy –about the local inflammation and the relation to the systemic inflammation in the stressful surgical procedures for patients-
Date of disclosure of the study information 2011/07/29
Last modified on 2011/07/28

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Basic information
Public title The relation of cytokine concentration in epithelial lining fluid and in peripheral blood HLA-DR during esophagectomy –about the local inflammation and the relation to the systemic inflammation in the stressful surgical procedures for patients-
Acronym The relation of cytokine concentration in epithelial lining fluid and in peripheral blood HLA-DR during esophagectomy –about the local inflammation and the relation to the systemic inflammation in the stressful surgical procedures for patients-
Scientific Title The relation of cytokine concentration in epithelial lining fluid and in peripheral blood HLA-DR during esophagectomy –about the local inflammation and the relation to the systemic inflammation in the stressful surgical procedures for patients-
Scientific Title:Acronym The relation of cytokine concentration in epithelial lining fluid and in peripheral blood HLA-DR during esophagectomy –about the local inflammation and the relation to the systemic inflammation in the stressful surgical procedures for patients-
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The correlation of the local inflammation and the systemic inflammation in the stressful surgical procedure for patients is evaluated by examining the proinflammatoly cytokines in epithelial lining fluid and in blood, and the relation of the HLA-DR expression of monocytes.
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to evaluate whether the expression of HLA-DR on monocytes is altered in patients undergoing esophagectomy.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase

Assessment
Primary outcomes Blood and epithelial lining fluid cytokine(IL-1beta,IL-6,IL-8,IL-10,TNFalpha,sICAM1,NFkappaB,)
HLA-DR expression on monocytes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 We used a bronchoscopic microsampling method to obtain epithelial lining fluid from lungs during esophagectomy.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Written informed concent
Key exclusion criteria Exclusion criteria included cardiac disease categorized as NYHA classes 2-4;preoperative severe impairment of respiratory function,such as a vital capacity of <50% or a forced expiratory volume in one second of <50% of that predicted;pre-existing coagulopathy or thrombocytopenia;and preoperative nonsurgical supplemental treatments such as immunotherapy.Patients were excluded if they had systemic or local active infections.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Yamaguchi
Organization Juntendo University School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 3-1-3Hongo,Bunkyo-ku,Tokyo 113-8431,Japan
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Saiko Wakabayashi
Organization Juntendo University School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 3-1-3Hongo,Bunkyo-ku,Tokyo 113-8431,Japan
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Department of anesthesiology and pain medicine Juntendo university school of medicine
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
2011 Year 07 Month 29 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 Preinitiation
Date of protocol fixation
2011 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 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
2011 Year 07 Month 28 Day
Last modified on
2011 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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