UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of perioperative administration of sivelestat sodium hydrate in patients underwent pancreatoduodenectomy
Title of the study (Brief title)	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	Fumihiko Miura
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	03-3964-1228
Email	f-miura@med.teikyo-u.ac.jp

Public contact
Name of contact person	Fumihiko Miura
Organization	Teikyo University School of Medicine
Division name	Department of Surgery
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL	03-3964-1228
Homepage URL
Email	f-miura@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000001522