UMIN-CTR Clinical Trial

Public title

The study for the hepatoprotective effect of steroid administration before hepatectomy in major hepatectomy with extrahepatic bile duct resection.

Acronym

The study for the hepatoprotective effect of steroid administration before hepatectomy.

Scientific Title

The study for the hepatoprotective effect of steroid administration before hepatectomy in major hepatectomy with extrahepatic bile duct resection.

Scientific Title:Acronym

The study for the hepatoprotective effect of steroid administration before hepatectomy.

Region

Japan

Condition

patients who are scheduled to undergo major hepatectomy with extrahepatic bile duct resection.

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To investigate the efficacy of preoperative steroid administration in preventing postoperative liver damage in patients who undergo major hepatectomy with extrahepatic bile duct resection.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

The incidence rate of posthepatectomy liver failure.

Key secondary outcomes

Postoperative liver injury.
Postoperative complications other than the liver failure.
Postoperative inhospital day.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

In the steroid group, hydrocortisone will be administered intravenously before hepatectomy (500mg), on postoperative day 1 (300mg), on postoperative day 2 (200mg), and on postoperative day 3 (100mg).

Interventions/Control_2

In the control group, same amount of saline will be administered in a same schedule as the steroid group.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who are scheduled to undergo major hepatectomy with extrahepatic bile duct resection (for any disease).
2. Patients who agree to participate in the study.

Key exclusion criteria

1. Patients who reject to participate in the study.
2. Patients who are not eligible to participate in the study (by decision of the investigators).

Target sample size

90

Name of lead principal investigator

1st name	Yukihiro
Middle name
Last name	Yokoyama

Organization

Nagoya University Graduate School of Medicine

Division name

Division of Surgical Oncology, Department of Surgery

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Aichi, Japan

TEL

0527442218

Email

yyoko@med.nagoya-u.ac.jp

Name of contact person

1st name	Yukihiro
Middle name
Last name	Yokoyama

Organization

Nagoya University Hospital

Division name

Gastrointestinal Surgery 1

Zip code

466-8550

Address

65 Tsurumai-cho, Showa-ku, Aichi, Japan

TEL

0527442218

Homepage URL

Email

yyoko@med.nagoya-u.ac.jp

Institute

Nagoya University

Institute

Department

Personal name

Organization

Nagoya University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagoya University Ethics Committee

Address

65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan

Tel

052-744-2061

Email

ethics@med.nagoya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

17

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Publication of results

Unpublished

URL related to results and publications

https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi

Number of participants that the trial has enrolled

94

Results

There were no significant differences between the groups in the incidence of grade B/C postoperative liver failure (control group, n = 8, 17%; steroid group, n = 4, 8%; p = 0.188)
and other complications. Serum bilirubin levels on PODs 2 and 3 were significantly lower in the steroid group than those in the control group; however, these median values were within normal limits in both groups.

Results date posted

2020

Year

12

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

06

Month

23

Day

Baseline Characteristics

Patients undergoing major hepatectomy with extrahepatic bile duct resection were included.

Participant flow

Patients were randomized into either the control or steroid groups.

Adverse events

There was no serious adverse events during study.

Outcome measures

Incidence of posthepatectomy liver failure.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2016

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

04

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

2019

Year

03

Month

31

Day

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

11

Month

29

Day

Last modified on

2020

Year

12

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028818