UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013823 |
|---|---|
| Receipt number | R000016025 |
| Scientific Title | Effect of preoperative steroids administration in laparoscopic hepatectomy with pedicle clamping: a prospective randomized study |
| Date of disclosure of the study information | 2014/04/28 |
| Last modified on | 2019/11/20 21:55:45 |
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Basic information
Public title
Effect of preoperative steroids administration in laparoscopic hepatectomy with pedicle clamping: a prospective randomized study
Acronym
RCT to evaluate steroids administration in laparoscopic hepatectomy with pedicle clamping
Scientific Title
Effect of preoperative steroids administration in laparoscopic hepatectomy with pedicle clamping: a prospective randomized study
Scientific Title:Acronym
RCT to evaluate steroids administration in laparoscopic hepatectomy with pedicle clamping
Region
| Japan |
Condition
Condition
Diseases planned to undergo laparoscopic liver resection(malignant/benign tumor, benign diseases)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There is no consensus on the beneficial effects of preoperative steroid administrations in patients undergoing laparoscopic hepatectomy with pedicle clamping. The aim of this prospective randomized controlled study is to investigate the clinical benefits of preoperative steroid administration.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Serum total bilirubin level
Key secondary outcomes
Serum AST, ALT, PPT-INR, CRP,and IL-6 levels . Postoperative complications and length of hospital stay.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The patients are assigned randomly to a control group or a steroid group in which patients received 500mg of methylprednisolone at induction.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who were planned to undergo pure laparoscopic liver resection, and their performance status were 0 or 1.
Key exclusion criteria
Difficult to undergo a surgery under general anesthesia. Patients with active infection, with uncontrollable diabetes mellitus, in pregnancy, or under 20-year-old.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Kobayashi |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
0208505
Address
Uchimaru 19-1, Morioka city, Iwate
TEL
019-651-5111
mdean@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Hasegawa |
Organization
Iwate Medical University School of Medicine
Division name
Department of Surgery
Zip code
0208505
Address
Uchimaru 19-1, Morioka city, Iwate
TEL
019-651-5111
Homepage URL
hasegawayas@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery, Iwate Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university school of medicine
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
Iwate Medical University School of Medicine
Address
Uchimaru 19-1, Morioka city, Iwate
Tel
019-651-5111
ikyomu@j.iwate-med.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
| 2014 | Year | 04 | Month | 28 | 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
130
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
| 2014 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 28 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016025
