UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006148 |
|---|---|
| Receipt number | R000007271 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2011/08/11 |
| Last modified on | 2017/01/30 12:50:18 |
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Basic information
Public title
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.
Acronym
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.
Scientific Title
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.
Scientific Title:Acronym
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CD4/8 ratio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
| 1st name | |
| Middle name | |
| Last name | Takeshi Kaneko |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
ycu.umin@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaharu Shinkai |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
shinkai@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
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
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 |
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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 21 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007271
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