UMIN-CTR Clinical Trial

Basic information
Public title	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer
Acronym	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)
Scientific Title	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer
Scientific Title:Acronym	Preventive effect of Sivelestat Na Hydrate on postoperative acute exacerbation of idiopathic interstitial pneumonia in the patient with lung cancer (Sivelestat trial)
Region	Japan

Condition
Condition	idiopathic interstitial pneumonia (IIP)
Classification by specialty	Pneumology Chest surgery Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the preventive effect of Sivelestat on postoperative acute exacerbation of IIP in patients suffering from lung cancer combined wiyh IIP
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	acute exacerbation of IIP within 30 postoperative days
Key secondary outcomes	30 postoperative day survival rate

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Control (n=30): intra- and postoperative management without Sivelestat
Interventions/Control_2	Trial (n=30): 7days administration of Sivelestat 0.2microgram/kgBW/hr div started from surgical operation
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	25 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Untreated patients with non-small-cell lung cancer who have plan of sergical treatment (2) Patients with IIP which shows ground-glass opacity or reticular pattern in both lungs on preoperative HR-CT
Key exclusion criteria	(1) With serious liver disorder (2) With serious renal dysfunction (3) With bleeding tentency (4) Patients registered in clinical trial of other drugs
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masayuki Chida
Organization	Dokkyo medical university
Division name	Department of general thoracic surgery
Zip code
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN
TEL	0282-86-1111
Email	chida-ths@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Sumiko Maeda
Organization	Dokkyo medical university
Division name	Department of general thoracic surgery
Zip code
Address	880 Kita-Kobayashi, Mibu-machi, Shimotsuga-gun Tochigi, JAPAN
TEL	0282-87-2160
Homepage URL
Email	sumaeda@dokkyomed.ac.jp

Sponsor
Institute	Japanese Northern East Area Thoracic Surgery Study Group (JNETS)
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	2016 Year 02 Month 19 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	Completed
Date of protocol fixation	2012 Year 01 Month 17 Day
Date of IRB	2013 Year 06 Month 08 Day
Anticipated trial start date	2013 Year 10 Month 21 Day
Last follow-up date	2020 Year 03 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 02 Month 19 Day
Last modified on	2019 Year 08 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024356