UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006062 |
|---|---|
| Receipt number | 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 16:58:48 |
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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
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
Sponsor or person
Institute
Department of anesthesiology and pain medicine Juntendo university school of medicine
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007176
