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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014667
Receipt No. R000017037
Scientific Title Efficiency of hydroxyethyl starch on circulatory dynamics in major abdominal surgery of hepatobiliary or pancreas system compared with using vasoconstrictive agents
Date of disclosure of the study information 2014/07/31
Last modified on 2014/07/27

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Basic information
Public title Efficiency of hydroxyethyl starch on circulatory dynamics in major abdominal surgery of hepatobiliary or pancreas system compared with using vasoconstrictive agents
Acronym Efficiency of hydroxyethyl starch on circulatory dynamics in major upper abdominal surgery
Scientific Title Efficiency of hydroxyethyl starch on circulatory dynamics in major abdominal surgery of hepatobiliary or pancreas system compared with using vasoconstrictive agents
Scientific Title:Acronym Efficiency of hydroxyethyl starch on circulatory dynamics in major upper abdominal surgery
Region
Japan

Condition
Condition surgical patients scheduled for hepatobiliary or pancreas systems
Classification by specialty
Hepato-biliary-pancreatic surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Abdominal surgery of hepatobiliary and pancreas system induces huge stress against surgical patients and fluctuates circulation. To maintain circulatory dynamics during such surgeries, vasoconstrictive drug such as alpha 1 agents or hydroxyethyl starch fluid is usually used. The aim of the present study is to investigate and compare those treatments from the standpoint of oxidative stress.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Oxidative stress is evaluated by measuring 8-OHdG in blood or urine before the start of surgery and the end of surgery. Intraoperative circulatory system is evaluated by esophageal echocardiography.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Two anesthetic managements are planned in cancer resection surgery of hepatobiliary or pancreas system. One is that circulation is maintained with the use of vasoconstrictive drugs (control).
Interventions/Control_2 The other is that circulation is maintained with the use of hydroxyethly starch fluid.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for cancer resection of hepatobiliary or pancreas system
Key exclusion criteria Patients with severe esophageal varices, esophageal ulcer or cancer, and problem of opening mouth.
Patients receiving esophageal cancer surgery.
Patients in whom operation method is changed during operation.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Tsuchiya
Organization Osaka City University Medical School
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-2186
Email oxymasa@ea.mbn.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Tsuchiya
Organization Osaka City University Medical School
Division name Department of Anesthesiology
Zip code
Address 1-5-7 Asahi-machi, Abeno-ku, Osaka, Japan
TEL 06-6645-2186
Homepage URL
Email oxymasa@ea.mbn.or.jp

Sponsor
Institute Department of Anesthesiology, Osaka City University Medical School
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
2014 Year 07 Month 31 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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 27 Day
Last modified on
2014 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017037

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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