UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025039 |
|---|---|
| Receipt number | R000028818 |
| Scientific Title | The study for the hepatoprotective effect of steroid administration before hepatectomy in major hepatectomy with extrahepatic bile duct resection. |
| Date of disclosure of the study information | 2016/12/17 |
| Last modified on | 2024/12/11 10:38:18 |
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Basic information
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
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
Objectives
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
Assessment
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.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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
Research contact person
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
yyoko@med.nagoya-u.ac.jp
Public contact
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
yyoko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Ethics Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi, Japan
Tel
052-744-2061
ethics@med.nagoya-u.ac.jp
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
| 2016 | Year | 12 | Month | 17 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 26 | Day |
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
| 2019 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028818
