UMIN-CTR Clinical Trial

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
Email	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
Email	hasegawayas@yahoo.co.jp

Sponsor
Institute	Department of Surgery, Iwate Medical University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016025