Bile leakage (BL) is the most frequent complication after liver resection. This study is to investigate the role of intraoperative administration of SMOFlipid 20% (fat emulsion which allows intraoperative identification of open bile ducts at the liver resection surface when it is administered retrograde through the cystic duct) in terms of prevention of postoperative BL within 30 days after surgery.
Patients who will receive an anatomical resection of two or more liver segments for any reason with simultaneous cholecystectomy in elective Setting
Patients who will receive an anatomical resection of two or more liver segments for any reason which already had a cholecystectomy if intraoperatively the cystic stump can be identified and opened
Ability of subject to understand character and individual consequences of the clinical Trial
Informed consent documented by signature
Previous cholecystectomy if intraoperative it is not possible to identify the cystic stump
Intraoperative hepatico-jejunostomy
Hypersensitivity to fish-, egg-, soybean or peanut protein or to any of the active ingredients or excipients
Immunosuppression, pregnancy
Parallel
"white" test" (= the administration of SMOFlipid retrograde through the cystic duct)
Drug"white" test" (= the administration of SMOFlipid retrograde through the cystic duct)
rate of postoperative bile leakage
Comparison of the rate of postoperative bile leakage in the control and in the intervention group. This is a binary endpoint defined by the presence or absence of the bile leakage (yes or no). Bile leakage is defined as bilirubin concentration in the drain fluid at least 3 times the serum bilirubin concentration on or after postoperative day 3.
Severity of the bile leakage (Grade A, B or C according to the definition by Koch et al).
The severity of bile leakage is classified according to its impact on patients´ clinical management. Grade A bile leakage causes no change in patients' clinical management. A Grade B bile leakage requires active therapeutic intervention but is manageable without relaparotomy, whereas in Grade C bile leakage relaparotomy is required.
In-hospital mortality other than related to the bile leakage
In-hospital mortality other than related to the bile leakage
In-Hospital morbidity other than related to the bile leakage
In-Hospital morbidity other than related to the bile leakage
Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no)
Endoscopic retrograde cholangio pancreatography (ERCP) (yes/no)
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Giulia Manzini
Lead sponsor
Kantonsspital Aarau
Sponsor institution
