Methylprednisolone and N- aceltylcisteine in hepatic resections

Active, not recruiting

Conditions: patients candidate to liver resection
MedDRA version: 14.1Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-003213-34-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Any sex, any race, any ethnicity Age > 18 Primary and secondary liver tumors Normal renal function Anticipated Pringle’s length > 30 minutes
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Renal failure of any grade ASA 4 Associate major surgery Intraoperative bleeding > 1500 ml Allergy to NAC or MET

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Secondary objective of the study is whether the reduction of ischemia-reperfusion injury results in: lower incidence of postoperative liver failure, improvement of postoperative liver function, and reduction of blood components transfusions;Primary end point(s): The primary endpoint of the study is the modulation of the IR injury made by NAC and/or MET in patients undergoing liver surgery. For this purpose a decrease of 100 UI/L of AST and ALT is expected compared with placebo;Timepoint(s) of evaluation of this end point: at the end of the operation, as well as in postoperative day 1, 3, 5 and 7;Main Objective: The primary objective of the study is to assess the real efficacy of MET and NAC in reducing the secondary damage from ischemia reperfusion injury in liver resection

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): evaluation difference in total bilirubin;Timepoint(s) of evaluation of this end point: at the end of the operation, as well as in postoperative day 1, 3, 5 and 7