UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study of the efficacy and safety of sivelestat sodium hydrate to prevent acute exacerbation after thoracoscopic lung biopsy in patients suspected of interstitial lung diseases whose bronchoalveolar fluid showed neutrophils.
Title of the study (Brief title)	The evaluation of prophylactic effect of sivelestat sodium hydrate against acute exacerbation after video-assisted thoracic surgery (VATS) in the patients suspected of interstitial lung diseases.
Region	Japan

Condition
Condition	interstitial lung disease
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For the patients undergoing VATS due to suspected interstitial lung diseases, this study investigates whether or not sivelestat has a prophylactic effect on exacerbation of lung function, even more on the progression of the disease.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The incidence of acute exacerbation for 2 weeks after VATS
Key secondary outcomes	<Efficacy endpoints> AUCPaO2(0-14day) Transition of various bio-markers in blood (LDH, CRP, SP-D, KL-6, HO (hemeoxygenase)-1, etc.) BALF findings (Total cell count, Cell fraction, LDH/TP/Alb&#61655;CD4/8 ratio&#61655;HO-1) Improvement in ground glass opacity in chest CT (Imaging site: the top of aortic bulb, carina and 1cm above the left diaphragmatic top) Improvement in the accumulation at lungs using gallium scintigraphy (-~+~+++) Pulmonary function test (FVC, VC, DLco, DLco/VA) AUCSpO2 in 6-min walk test (room air) Blood gas analysis The correlation between VATS findings (cellular infiltration into alveolar space) and the improvement in the disease activity. The correlation between HO-1 immunohistochemical staining and the improvement in the disease activity. The correlation of the neutophil counts in the BALF and the improvement in the disease activity. The incidence of acute exacerbation of interstitial pneumonia after 3 and 6 months Acute exacerbation is diagnosed when a patient meets all the following criteria: 1) increased dyspnea, 2) honeycomb lung and new ground glass opacity / infiltration and 3) decreased arterial oxygen fraction (PaO2: 10 Torr under the same condition. Marked pulmonary infection, pneumothorax, malignant tumor, pulmonary embolism and heart failure are excluded.) <Safety endpoint> The number and the rate of incidents item by item for each adverse event.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sivelestat is administered 0.2 mg/ kg/ h for the duration of less than 14 days just after VATS
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Patients 20<=and<=75 years old 2) Patients with neutrophils in bronchoalveolar lavage fluid (regardless of the proportion) 3) Inpatient 4) Patients who are suspected to be interstitial lung disease and undergoing VATS 5) Patients who offer a documented agreement to the study
Key exclusion criteria	1) Patients complicated by four or more organ failures including lungs 2) Patients in pregnancy, lactation, or possible pregnancy 3) Patients to whom the physician in-charge judged not suitable for the study 4) Patients using steroid 5) Patients who against or depart gravely from the protocol in dose, dosing schedule, and/or the combination of therapy
Target sample size	12

Research contact person
Name of lead principal investigator	Takeshi Kaneko
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	ycu.umin@gmail.com

Public contact
Name of contact person	Masaharu Shinkai
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	shinkai@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
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)

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	横浜市立大学附属市民総合医療センター（神奈川県） 防衛医科大学校病院　感染症・呼吸器内科（埼玉県）

Other administrative information
Date of disclosure of the study information	2011 Year 08 Month 11 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 07 Month 21 Day
Anticipated trial start date	2011 Year 08 Month 01 Day
Last follow-up date	2017 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 11 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007271