UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001249 |
|---|---|
| Receipt number | R000001522 |
| Scientific Title | Evaluation of perioperative administration of sivelestat sodium hydrate in patients underwent pancreatoduodenectomy |
| Date of disclosure of the study information | 2008/07/21 |
| Last modified on | 2019/02/27 18:37:19 |
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Basic information
Public title
Evaluation of perioperative administration of sivelestat sodium hydrate in patients underwent pancreatoduodenectomy
Acronym
Perioperative administration of sivelestat in patients underwent PD
Scientific Title
Evaluation of perioperative administration of sivelestat sodium hydrate in patients underwent pancreatoduodenectomy
Scientific Title:Acronym
Perioperative administration of sivelestat in patients underwent PD
Region
| Japan |
Condition
Condition
Periampullary disease requiring panceatoduodenectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of the present study is to evaluate efficacy of perioperative administration of sivelestat sodium hydrate in patients underwent pancreatoduodenectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of acute lung injury
Key secondary outcomes
Incidence of postoperative complication
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
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Perioperative administration of sivelestat sodium hydrate
Interventions/Control_2
Perioperative non-administration of sivelestat sodium hydrate
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients from whom informed consent was obtained
Key exclusion criteria
1.Previous history of hypersensitibity to sivelestat sodium hydrate
2.Increase in left atrial pressure
3.Multiple organ dysfunction
4.Doctor's decision not to register to this regimen
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiko Miura |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1228
f-miura@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fumihiko Miura |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1228
Homepage URL
f-miura@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
self funding
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 21 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001522
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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