Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000605493
Ethics application status
Approved
Date submitted
16/11/2007
Date registered
26/11/2007
Date last updated
26/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Modulation of systemic reaction to operation in liver surgery: A prospective randomised study on the Impact of preoperative steroids administration on systemic responses to liver surgery
Scientific title
Impact of preoperative steroids administration on surgical stress in patients undergoing liver surgery
Universal Trial Number (UTN)
Trial acronym
MIRP002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients undergoing liver surgery for benign and malignant disease 2559 0
Condition category
Condition code
Surgery 2661 2661 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single Intravenous Administration of 500 mg of methylprednisolone at the induction of anaesthesia. Several markers of surgical stress, liver function and coagulation were evaluated for 5 days after the surgical procedure. Postoperative complication were evaluated until post operative day 30.
Intervention code [1] 2293 0
Treatment: Surgery
Comparator / control treatment
Control: Saline solution - used instead of methylprednisolone.
Control group
Placebo

Outcomes
Primary outcome [1] 3571 0
Serum levels of tumor necrosis factor alpha (TNF) and interleukin 6 (IL-6), as indicators of the surgical stress response, were measured at the induction of anaesthesia
and on post operative day (POD) 1, 2 and 5. Serum levels were quantified by
using an enzyme linked immunosorbent assay kit according to the manufacturer's specifications (Bouty,
Milan, Italy). Samples were centrifuged at 3000 rpm for
10 minutes and stored at 80 degrees Celsius until analysis. Data
were then presented as picograms per millilitre. The
detection limit of the assay was 1 pg/mL for TNF- and 0.1 pg/mL for IL-6.
Postoperative complications
Timepoint [1] 3571 0
Postoperative complication (30 days)
Secondary outcome [1] 5976 0
Liver function : Bilirubin
Hepatic ischemia reperfusion : alanine aminotransferase (ALT)
Coagulation homeostasis : antithrombin III (AT-III), prothrombin time-international
normalized ratio, fibrinogen, D dimer, and platelets
Timepoint [1] 5976 0
Postoperative day 1,2, and 5

Eligibility
Key inclusion criteria
Patients undergoing liver surgery for benign and malignant disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Concomitant extrahepatic surgery
-Intraoperative radiofrequency
-Suspected active infective disease

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 664 0
Italy
State/province [1] 664 0

Funding & Sponsors
Funding source category [1] 2804 0
Self funded/Unfunded
Name [1] 2804 0
Department of Surgery
Liver Unit
Scientific Institute San Raffaele
Country [1] 2804 0
Italy
Primary sponsor type
Individual
Name
Luca Aldrighetti
Address
Department of Surgery
Liver Unit
Scientific Institute San Raffaele
Via Olgettina 60
20132 Milan
Country
Italy
Secondary sponsor category [1] 2534 0
None
Name [1] 2534 0
Address [1] 2534 0
Country [1] 2534 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Preoperative steroid administration may represent a safe and effective modulator of surgical stress, may reduce hepatic ischemia reperfusion injury, maintain
coagulant/anticoagulant homeostasis, and reduce postoperative complication by modulating the inflammatory
response.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28193 0
Address 28193 0
Country 28193 0
Phone 28193 0
Fax 28193 0
Email 28193 0
Contact person for public queries
Name 11350 0
Carlo Pulitanò
Address 11350 0
Department of Surgery
Liver Unit
Scientific Institute San Raffaele
Via Olgettina 60
20132 Milan
Country 11350 0
Italy
Phone 11350 0
+39 02 26437808
Fax 11350 0
Email 11350 0
[email protected]
Contact person for scientific queries
Name 2278 0
Carlo Pulitanò
Address 2278 0
Department of Surgery
Liver Unit
Scientific Institute San Raffaele
Via Olgettina 60
20132 Milan
Country 2278 0
Italy
Phone 2278 0
+39 02 26437808
Fax 2278 0
Email 2278 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.