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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001944
Receipt No. R000002364
Scientific Title Perioperative steroids administration in hepatectomy: A prospective randomized study
Date of disclosure of the study information 2009/05/07
Last modified on 2010/11/06

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Basic information
Public title Perioperative steroids administration in hepatectomy: A prospective randomized study
Acronym Perioperative steroids administration in hepatectomy
Scientific Title Perioperative steroids administration in hepatectomy: A prospective randomized study
Scientific Title:Acronym Perioperative steroids administration in hepatectomy
Region
Japan

Condition
Condition The patients who were planned to hepatic resection in the Department of Digestive Surgery at Nihon University Itabashi Hospital, Tokyo, Japan.
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 There is no consensus on the beneficial effects of perioperative steroid administrations in patients undergoing hepatectomy. The aim of this prospective randomized controlled study was to investigate the clinical benefits of perioperative steroid administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes The primary endpoint was serum level of total bilirubin (T.bil) on POD2.
Key secondary outcomes The other serum levels related to liver function, inflammatory cytokine levels, and postoperative complications were also compared between the two groups.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients were assigned randomly to a control group or a steroid group in which patients received 500mg of hydrocortizon just before hepatic pedicle clamping, 300mg on postoperative day (POD) 1, 200mg on day2 and 100mg on day3.
Interventions/Control_2 administration only saline solution
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
15 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Eligibility criteria included from 15 to 84 years patients who were planned to hepatic resection and had adequate functional reserve of the heart, lungs, and kidneys. Patients were excluded who if they had already treated with taken steroids, had unstable condition of gastric ulcer or past history of acute myocardial infarction. Randomization stratified by Child-Pugh class (A or B)
Key exclusion criteria Eligibility criteria included from 15 to 84 years patients who were planned to hepatic resection and had adequate functional reserve of the heart, lungs, and kidneys. Patients were excluded who if they had already treated with taken steroids, had unstable condition of gastric ulcer or past history of acute myocardial infarction. Randomization stratified by Child-Pugh class (A or B)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Yamazaki
Organization Nihon University School of Medicine
Division name Department of Digestive Surgery
Zip code
Address 30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo
TEL 03-3972-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Yamazaki
Organization Nihon University School of Medicine
Division name Department of Digestive Surgery
Zip code
Address
TEL
Homepage URL
Email yamazaki-nmed@umin.ac.jp

Sponsor
Institute Nihon University School of Medicine, Itabashi Hospital
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research from the Ministry of Education Science and Culture of Japan.
Organization
Division
Category of Funding Organization
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
2009 Year 05 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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
2006 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 07 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 06 Day
Last modified on
2010 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002364

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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