Phase
Condition
Liver Disease
Liver Failure
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
male or female patients of 18 years or older which are able to give informed consentwith indication for surgical partial liver resection according to OPS code 5-502; thisincludes benign and malign tumors.
patients with pre-surgical thin-layer CT or MRT of the liver not older than 6 weeks orpatients where a pre-surgical thin-layer CT or MRT of the liver is planned beforesurgery.
written informed consent
Exclusion
Exclusion Criteria: at screening:
anamnestic known hypersensitivity against one of the study drugs, their ingredients ordrugs with chemically similar structure (in particular paracetamol)
participation in another clinical trials within 4 weeks before inclusion
patients with previous liver surgery (OPS-Code 5-502), including biliodigestiveanastomosis, excluding cholecystectomy.
patients which underwent interventions such as radiofrequency ablation, biopsies orsmaller surgeries within 6 weeks before inclusion
patients anticipated for biliodigestive anastomosis and/or suffering from aKlatskin-tumor
patients with a ASA (American Society of Anesthesiologists) classification >3
patients anticipated for laparoscopic partial liver resection
patients which are intended to be simultaneously treated with an interventionaltechnique (e.g. radio frequency ablation RFA, embolization)
patients which are intended to simultaneously get a surgery on other organs (excludingcholecystectomy)
patients which are intended to simultaneously get a vascular anastomosis (e.g. portalvein resection)
patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)
patients with congenital metabolic diseases, in particular hepatic storage diseases
hepatic infection with Echinococcus multilocularis
patients with known non-infectious, auto-immune conditioned chronic inflammatorydiseases (e.g. autoimmune hepatitis, Morbus Crohn, colitis ulcerativa)
patients with severe cardiovascular diseases and/or severe diseases of the respiratorysystem which receive intensive care in any case (e.g. heart surgery, bypass surgery,cardiac valve replacement, unstable angina pectoris, severe coronary heart diseasewith intervention during the last 6 months, severe COPD (chronic obstructive pulmonarydisease), severe asthma with concomitant cortisone medication)
patients with severe bacterial infection at screening
patients with known immunodeficiency
heavy smokers (>20 cigarettes a day)
patients which are unable to understand the study and its possible implicationsbecause of addiction or other diseases
patients who are suspected not to cooperate or to comply to the trial protocol
patients accommodated in an institution due to public or legal authority
pregnant or lactating women
women with child-bearing potential, excluding: negative pregnancy test and commitmentto be sexually inactive until day 30 after surgery or discharge; postmenopause (12months of natural occurring amenorrhoea); at least 6 weeks after ovariectomy with orwithout hysterectomy at visit 2:
patients anticipated for laparoscopic partial liver resection
patients which are intended to be simultaneously treated with an interventionaltechnique (e.g. radio frequency ablation RFA, embolization)
patients which are intended to simultaneously get a surgery on other organs (excludingcholecystectomy)
patients which are intended to simultaneously get a vascular anastomosis (e.g. portalvein resection)
patients with known hepatic cirrhosis or known severe fibrosis (e.g. Ishak-score grade >4)
hepatic infection with Echinococcus multilocularis
patients with severe cardiovascular diseases and/or severe diseases of the respiratorysystem which receive intensive care in any case (e.g. heart surgery, bypass surgery,cardiac valve replacement, unstable angina pectoris, severe coronary heart diseasewith intervention during the last 6 months, severe COPD (chronic obstructive pulmonarydisease), severe asthma with concomitant cortisone medication)
patients anticipated for biliodigestive anastomosis and/or suffering from aKlatskin-tumor
patients with a ASA (American Society of Anesthesiologists) classification >3
Study Design
Connect with a study center
Dept. of General-, Visceral- and Graft Surgery, Aachen University Hospital
Aachen, 52074
GermanySite Not Available
Dept. of General-, Visceral- and Graft Surgery, Charité Campus Virchow-Hospital
Berlin, 13353
GermanySite Not Available
Dept. of General- and Visceral Surgery, Jena University Hospital
Jena, 07747
GermanySite Not Available
Clinic and Policlinic for Visceral-, Graft-, Thorax- and Vascular Surgery, Leipzig University Hospital
Leipzig, 04103
GermanySite Not Available
Clinic and Policlinic for General- Visceral- and Graft Surgery, Würzburg University Hospital
Würzburg, 97080
GermanySite Not Available
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