UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014667
Receipt number 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 22:19:15

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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 or person

Institute

Department of Anesthesiology, Osaka City University Medical School

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


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

Value
https://center6.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