UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001944
Receipt number 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 18:37:19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Nihon University School of Medicine, Itabashi Hospital

Institute

Department

Personal name



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

Value
https://center6.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