UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034488
Receipt number R000039330
Scientific Title Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy
Date of disclosure of the study information 2018/10/15
Last modified on 2018/10/14 23:26:51

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Basic information

Public title

Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy

Acronym

Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy

Scientific Title

Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy

Scientific Title:Acronym

Investigation on exhaled nitrogen chemicals in lung cancer patients undergoing lobectomy

Region

Japan


Condition

Condition

lobectomy

Classification by specialty

Chest surgery Anesthesiology Intensive care medicine
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

For patients with lung cancer who undergo lobectomy, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate not only the relevance between collapsed lung and non-collapsed lung but also the relevance to blood ROS, blood cytokines, and pulmonary function.

Basic objectives2

Others

Basic objectives -Others

epidemiology research

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

change in exhaled NO, NO2, HONO concentration during perioperative period

Key secondary outcomes

1) relevance of exhaled NO, NO2, HONO and collapsed lung and non-collapsed lungs during perioperative period
2) relevance of exhaled NO, NO2, HONO and blood ROS during perioperative period
3) relevance of exhaled NO, NO2, HONO and blood cytokines during perioperative period
4) relevance of exhaled NO, NO2, HONO and pulmonary function during perioperative period
5) relevance of exhaled NO, NO2, HONO and duration of collapse pulmonary during perioperative period


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) patients over 20 years at the time of obtaining informed consent
2) patients with lung cancer up to stage II
3) patients scheduled for lobectomy
4) patients with ASA PS 1 to 2

Key exclusion criteria

1) patients undergoing surgery requiring general anesthesia within 3 months prior to obtaining informed consent
2) patients with heart disease
3) patients with arrhythmia
4) patients with poor control hypertenson
5) patients with respiratory dysfunction
6) patients with lung disease
7) patients with smoking history within 3 months before consent acquisition
8) patients with pulmonary hypertension
9) diabetic patients with poor control
10) patients with cerebrovascular disorders
11) patients with severe liver disease
12) patients with severe kidney disease
13) patients with declining blood clotting ability
14) patients with thrombocytopenia
15) patients who receive chemotherapy, radiation therapy, immunotherapy within 3 months prior to obtaining informed consent
16) patients with systemically or locally active infections
17) highly obese patients
18) women who may be pregnant or have a possibility of pregnancy
19) patients who received study drugs or investigational drugs within 3 months prior to obtaining informed consent
20) patinets whom research investigator has determined to be inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazumi Funaki

Organization

Tottori University

Division name

Division of Anesthesiology and Critical Care Medicine

Zip code


Address

36-1, Nishi-cho, Yonago, Tottori, Japan

TEL

0859-38-6657

Email

funapon1116@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kazumi Funaki

Organization

Tottori University

Division name

Division of Anesthesiology and Critical Care Medicine

Zip code


Address

36-1, Nishi-cho, Yonago, Tottori, Japan

TEL

0859-38-6657

Homepage URL


Email

funapon1116@gmail.com


Sponsor or person

Institute

Division of Anesthesiology and Critical Care Medicin, Tottori University

Institute

Department

Personal name



Funding Source

Organization

Division of Anesthesiology and Critical Care Medicin, Tottori University

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

鳥取大学医学部附属病院(鳥取県)


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 15 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

2018 Year 08 Month 06 Day

Date of IRB


Anticipated trial start date

2018 Year 10 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

For patients with lung cancer who undergo lobectomy, to measure the concentration of exhaled nitrogen chemicals (NO, NO2, HONO) at the perioperative period and to evaluate the effect of surgery. Also, to evaluate not only the relevance between collapsed lung and non-collapsed lung but also the relevance to blood ROS, blood cytokines, and pulmonary function.


Management information

Registered date

2018 Year 10 Month 14 Day

Last modified on

2018 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name