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

* 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

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

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

esophageal cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

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

Dynamic allocation

Institution consideration

Blocking

Concealment

No need to know

Intervention

No. of arms

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name