This study investigates if the administration of terlipressin reduces complications after major liver surgery.
Background Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. The prerequisite for successful and safe liver surgery is the optimal regeneration of the remaining hepatic tissue in order to fulfill the metabolic demands of the patient. Liver regeneration depends on a correct portal pressure and portal blood flow. In the preliminary results the investigators show an elevation of portal pressure post partial hepatectomy in mice. Pharmacologic reduction of such elevated portal pressure using terlipressin, a vasopressin agonist, was associated with improved liver regeneration. Objective Surgery offers the only potential cure in many patients with primary or metastatic liver cancer. Extending the limits and improving safety of liver resection would allow more patients to benefit from surgery and to increase their survival. Liver regeneration depends on a correct portal pressure and portal blood flow. Pharmacologic reduction of elevated portal pressure using terlipressin, a vasopressin agonist, is potentially associated with improved liver regeneration. Aim: To perform a prospective randomized trial comparing terlipressin versus placebo in patients undergoing major hepatic resection. Methods
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg).
Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
Dep. of Visceral Surgery, University Hospital Berne
Bern, Switzerland
Number of patients with incident of a composite end point
Time frame: one month
Number of patients with pleural effusion
Time frame: one month
Number of patients with surgical site infection
Time frame: one month
Number of patients with sepsis
Time frame: one month
Number of patients with pneumonia
Time frame: one month
Number of patients with intraabdominal hematoma
Time frame: one month
Number of patients with acute renal failure
Time frame: one month
Number of patients with blood transfusion
Time frame: one month
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